ORCA Foam

GUDID 00860003109991

AbsorbaleGelatin Sponge

Orca Products, LLC

Gelatin haemostatic agent
Primary Device ID00860003109991
NIH Device Record Key30bc6591-9055-4c0f-b045-2af27756b041
Commercial Distribution StatusIn Commercial Distribution
Brand NameORCA Foam
Version Model NumberSze 100
Company DUNS117716283
Company NameOrca Products, LLC
Device Count4
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003109991 [Unit of Use]
GS110860003109998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYASplint, Intranasal Septal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-04
Device Publish Date2022-02-24

On-Brand Devices [ORCA Foam]

10860003109912AbsorbaleGelatin Sponge
00860008294302AbsorbaleGelatin Sponge
00860003109991AbsorbaleGelatin Sponge
00860003109984AbsorbaleGelatin Sponge
00860003109977AbsorbaleGelatin Sponge
00860008294340AbsorbaleGelatin Sponge
00860008294371AbsorbaleGelatin Sponge
00860008294364AbsorbaleGelatin Sponge
00850056665018AbsorbaleGelatin Sponge
00860008294395AbsorbaleGelatin Sponge

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