POD

GUDID M242RBYPODJ150

RBYPODJ15 GS1-00814548016702

PENUMBRA, INC.

Embolization implant kit
Primary Device IDM242RBYPODJ150
NIH Device Record Key88a67faa-3869-4f3c-bcd2-5c1bdd55b162
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOD
Version Model NumberRBYPODJ15
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM242RBYPODJ150 [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 Date2024-08-23
Device Publish Date2024-08-15

On-Brand Devices [POD]

00814548019673POD, 14x60
00814548019666POD, 12x60
00814548019659POD, 10x60
00814548019642POD, 9x60
00814548019635POD, 8x60
00814548019628POD, 7x60
00814548019611POD, 6x50
00814548019604POD, 5x30
00814548019598POD, 4x30
00814548019581POD, 3x20
00814548017679RBYPODJ60
00814548017662RBYPODJ45
00814548017655RBYPODJ30
00814548017648RBYPODJ15
00814548017631RBYPODJ5
00815948020351POD Neuro, 6x50
00815948020344POD Neuro, 5x30
00815948020337POD Neuro, 4x30
00815948020320POD Neuro, 3x20
M424RBYPODJ450RBYPODJ45
M242RBYPODJ150RBYPODJ15 GS1-00814548016702

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