DEFENDO Biopsy Valve Irrigator

GUDID 00677964060281

MEDIVATORS INC.

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Primary Device ID	00677964060281
NIH Device Record Key	789c919b-0a69-4ffc-a845-61e3f2250b0e
Commercial Distribution Status	In Commercial Distribution
Brand Name	DEFENDO Biopsy Valve Irrigator
Version Model Number	100303
Company DUNS	068199363
Company Name	MEDIVATORS INC.
Device Count	1
DM Exempt	false
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	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964060281 [Primary]
GS1	10677964060288 [Package] Package: Carton [10 Units] In Commercial Distribution
GS1	20677964060285 [Package] Package: Case [50 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110088

FDA Product Code

ODC	Endoscope Channel Accessory

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-08-15
Device Publish Date	2016-09-21

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