C-Sponge CSII100

GUDID D867CSII001

Pharyngeal barrier

Xemax Surgical Products Inc

Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad

Primary Device ID	D867CSII001
NIH Device Record Key	98193293-932f-44b3-9a18-d4f57bd0f17f
Commercial Distribution Status	In Commercial Distribution
Brand Name	C-Sponge
Version Model Number	II
Catalog Number	CSII100
Company DUNS	804495695
Company Name	Xemax Surgical Products Inc
Device Count	100
DM Exempt	false
Pre-market Exempt	true
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	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D867CSII001 [Unit of Use]
HIBCC	D867CSII1000 [Primary]

FDA Product Code

NAB	Gauze / Sponge,Nonresorbable For External Use