623 - Certi-Gauze Bandage Compress - 3" - 2/Unit R211-005

GUDID 00766588110059

623 - Certi-Gauze Bandage Compress - 3" - 2/Unit

Certified Safety Manufacturing, Inc.

Non-woven gauze pad
Primary Device ID00766588110059
NIH Device Record Keyc08d088f-5b22-467b-94a9-007e575d201a
Commercial Distribution StatusIn Commercial Distribution
Brand Name623 - Certi-Gauze Bandage Compress - 3" - 2/Unit
Version Model NumberR211-005
Catalog NumberR211-005
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
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
GS100766588110059 [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 Date2023-04-04
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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