ORCA Foam Powder

GUDID 00850056665117

AbsorbaleGelatin Powder

Orca Products, LLC

Gelatin haemostatic agent
Primary Device ID00850056665117
NIH Device Record Key23b9a1d6-4b16-4089-b6bc-eb65969452c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameORCA Foam Powder
Version Model NumberOF-01B
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
GS100850056665117 [Unit of Use]
GS100850056665124 [Primary]

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 Date2024-12-13
Device Publish Date2024-12-05

On-Brand Devices [ORCA Foam Powder]

00850056665131AbsorbaleGelatin Powder
00850056665117AbsorbaleGelatin Powder
00850056665094AbsorbaleGelatin Powder

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