POD Packing

GUDID 00814548017709

Packing Coil 4cm

PENUMBRA, INC.

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil
Primary Device ID00814548017709
NIH Device Record Key0e5b609a-eaef-497b-97b1-973be7ee3b4d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOD Packing
Version Model NumberRBYPODJ4-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548017709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-04
Device Publish Date2021-02-24

On-Brand Devices [POD Packing]

00814548017822Packing Coil 55cm
00814548017815Packing Coil 50cm
00814548017808Packing Coil 40cm
00814548017792Packing Coil 35cm
00814548017785Packing Coil 25cm
00814548017778Packing Coil 20cm
00814548017761Packing Coil 12cm
00814548017754Packing Coil 10cm
00814548017747Packing Coil 9cm
00814548017730Packing Coil 8cm
00814548017723Packing Coil 7cm
00814548017716Packing Coil 6cm
00814548017709Packing Coil 4cm
00814548017693Packing Coil 3cm
00814548017686Packing Coil 2cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.