638 - Certi-Gauze Compress - 18"x 36" - 2/Unit R211-014

GUDID 00766588110141

638 - Certi-Gauze Compress - 18"x 36" - 2/Unit

Certified Safety Manufacturing, Inc.

Non-woven gauze pad
Primary Device ID00766588110141
NIH Device Record Key5cd780b9-6a2d-4d19-aedb-5349bddd6756
Commercial Distribution StatusIn Commercial Distribution
Brand Name638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
Version Model NumberR211-014
Catalog NumberR211-014
Company DUNS788460483
Company NameCertified Safety Manufacturing, Inc.
Device Count1
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com
Phone+1(816)483-9090
EmailInfo@certifiedsafety.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100766588110141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFQGAUZE/SPONGE, INTERNAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-07
Device Publish Date2023-01-27

Devices Manufactured by Certified Safety Manufacturing, Inc.

00766588244204 - Class A 21 Plus - 24 Poly White2025-04-04 Class A 21 Plus - 24 Poly White
00766588249070 - Class A 21 Assortment Pack2025-04-04 Class A 21 Assortment Pack
00766588249094 - Class A 21 Plus - 16 Poly White2025-04-04 Class A 21 Plus - 16 Poly White
00766588249186 - Class A 21 Plus - RTB 51862025-04-04 Class A 21 Plus - RTB 5186
00766588257006 - Class A 21 Plus/CTB - 24 Poly White2025-04-04 Class A 21 Plus/CTB - 24 Poly White
00766588257013 - Class A 21 Plus/BBP - 24 Poly White2025-04-04 Class A 21 Plus/BBP - 24 Poly White
00766588257037 - Class A 21 Plus/BBP/CTB - 36 Metal2025-04-04 Class A 21 Plus/BBP/CTB - 36 Metal
00766588247045 - Heat Stress - 10 Poly White2025-04-01 Heat Stress - 10 Poly White
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