ORCA Foam

GUDID 10860003109912

Gelatin haemostatic agent

Primary Device ID	10860003109912
NIH Device Record Key	1c470ab0-aece-4e6c-80ae-562cabe0e902
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORCA Foam
Version Model Number	Standard
Company DUNS	117716283
Company Name	Orca Products, LLC
Device Count	50
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	00860003109915 [Primary]
GS1	00860003109922 [Unit of Use]
GS1	10860003109912 [Package] Contains: 00860003109915 Package: Case [12 Units] In Commercial Distribution

LYA	Splint, Intranasal Septal

Steralize Prior To Use	false
Device Is Sterile	true

10860003109912	AbsorbaleGelatin Sponge
00860008294302	AbsorbaleGelatin Sponge
00860003109991	AbsorbaleGelatin Sponge
00860003109984	AbsorbaleGelatin Sponge
00860003109977	AbsorbaleGelatin Sponge
00860008294340	AbsorbaleGelatin Sponge
00860008294371	AbsorbaleGelatin Sponge
00860008294364	AbsorbaleGelatin Sponge
00850056665018	AbsorbaleGelatin Sponge
00860008294395	AbsorbaleGelatin Sponge
00850056665186	AbsorbaleGelatin Sponge (125mmx80mmx2mm)
00850056665216	AbsorbaleGelatin Sponge (80mm x 30mm cylinder)