ORCA Foam Powder

GUDID 00850056665094

Gelatin haemostatic agent

Primary Device ID	00850056665094
NIH Device Record Key	caa8a146-38dc-4404-9910-23a59fe6ec22
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORCA Foam Powder
Version Model Number	OF-01
Company DUNS	117716283
Company Name	Orca Products, LLC
Device Count	6
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850056665094 [Unit of Use]
GS1	00850056665100 [Primary]

LYA	Splint, Intranasal Septal

Steralize Prior To Use	false
Device Is Sterile	true