Primeros QA-224

GUDID 09556807313801

Natural latex male condom. Transparent, anatomically shaped, flared, nominal width 54 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested.

RICHTER RUBBER TECHNOLOGY SDN. BHD.

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Primary Device ID	09556807313801
NIH Device Record Key	573cbbdf-aed1-44cb-99a9-b785013f0223
Commercial Distribution Status	In Commercial Distribution
Brand Name	Primeros
Version Model Number	Nighthawk 3's
Catalog Number	QA-224
Company DUNS	652647942
Company Name	RICHTER RUBBER TECHNOLOGY SDN. BHD.
Device Count	3
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	09556807313801 [Unit of Use]
GS1	19556807313792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070511

FDA Product Code

HIS

Condom

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-10
Device Publish Date	2024-05-02

On-Brand Devices [Primeros ]

09556807313863	Natural latex male condom. Transparent, anatomically shaped, dotted ribbed contoured, nominal wi
09556807313849	Natural latex male condom. Transparent, cylindrical shaped, ultra thin, nominal width 53 mm, smo
09556807313825	Natural latex male condom. Transparent, cylindrical shaped, ultra-thin, nominal width 53 mm, smo
09556807313801	Natural latex male condom. Transparent, anatomically shaped, flared, nominal width 54 mm, smooth
19556807313778	Natural latex male condom. Transparent, cylindrical-shaped, nominal width 53 mm, smooth with res
09556807313948	Natural latex male condom. Transparent, Thick flared condom, nominal width 54 mm, smooth with re
09556807313924	Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
09556807313900	Natural latex male condom. Transparent, flared shaped, nominal width 57 mm, smooth with reservoi
09556807313887	Natural latex male condom. Transparent, flared ribbed & dotted, nominal width 56 mm, smooth with
09556807304243	Natural latex male condom. Transparent, anatomically shaped, nominal width 53 mm & 54 mm,with re
09556807304229	Natural latex male condom. Transparent, anatomical & cylindrical shaped, plain condom, flared co
09556807304205	Natural latex male condom. Transparent, anatomical & cylindrical shaped, plain condom, dotted ri
09556807304182	Natural latex male condom. Transparent, anatomical & cyclindrical shaped, plain condom, flared c
09556807304168	Natural latex male condom. Transparent, plain condom, cylindrical shaped, nominal width 53 mm an
09556807304144	Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
09556807304120	Natural latex male condom. Transparent, plain condom, flared & dotted condom,nominal width 53 mm
09556807304106	Natural latex male condom. Transparent, plain condom, dotted & ribbed condom, nominal width 53 m
09556807304083	Natural latex male condom. Transparent, plain condom, flared condom, thick flared condom, dotted

Trademark Results [Primeros]

Mark Image Registration \| Serial	Company Trademark Application Date
PRIMEROS 97059505 not registered Live/Pending	PRIMEROS LLC 2021-10-05
PRIMEROS 79032017 not registered Dead/Abandoned	Davidoff & Cie SA 2006-11-15
PRIMEROS 78331528 not registered Dead/Abandoned	SOUTHERN SMOKE LLC 2003-11-21