CEREPAKTM MDH1

GUDID 10886704084600

CEREPAKTM detacher

Cerenovus, Inc.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

Primary Device ID	10886704084600
NIH Device Record Key	31d29ba1-c891-4137-9068-1a8eb755625a
Commercial Distribution Status	In Commercial Distribution
Brand Name	CEREPAKTM
Version Model Number	MDH1
Catalog Number	MDH1
Company DUNS	607846297
Company Name	Cerenovus, 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

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704084600 [Primary]

FDA Product Code

KRD	Device, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2024-05-10
Device Publish Date	2022-09-15

Devices Manufactured by Cerenovus, Inc.

10886704083610 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2 mm Coil Length - 1.5 cm
10886704083627 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2 mm Coil Length - 2 cm
10886704083634 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 3 mm Coil Length - 4 cm
10886704083641 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 3 mm Coil Length - 6 cm
10886704083658 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 3 mm Coil Length - 8 cm
10886704083665 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 4 mm Coil Length - 6 cm
10886704083672 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 4 mm Coil Length - 8 cm
10886704083689 - CEREPAK FREEFORM	2024-05-14 CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 4 mm Coil Length - 10 cm