ORCA Foam Powder

GUDID 10850056665244

"AbsorbaleGelatin Powder--Pre-filled 1g Syringe "

Orca Products, LLC

Gelatin haemostatic agent
Primary Device ID10850056665244
NIH Device Record Key6f7bfb72-dba7-4558-acac-84748ed6dffb
Commercial Distribution StatusIn Commercial Distribution
Brand NameORCA Foam Powder
Version Model NumberOF-PS-10
Company DUNS117716283
Company NameOrca Products, LLC
Device Count6
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

Customer Support Contacts

Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com
Phone334-803-2370
Emailcdsdds@me.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850056665247 [Primary]
GS110850056665244 [Unit of Use]

FDA Product Code

KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-15
Device Publish Date2025-04-07

On-Brand Devices [ORCA Foam Powder]

00850056665131AbsorbaleGelatin Powder
00850056665117AbsorbaleGelatin Powder
00850056665094AbsorbaleGelatin Powder
10850056665244"AbsorbaleGelatin Powder--Pre-filled 1g Syringe "

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