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.

00766588250076 - Safety General Purpose - 10 Poly White2025-12-26 Safety General Purpose - 10 Poly White
00766588235745 - 628 - Non-Stick Pads 2"x 3" - 4/unit2025-12-25 628 - Non-Stick Pads 2"x 3" - 4/unit
00766588120676 - RR - UP Facilities - 75V2025-12-23 RR - UP Facilities - 75V
00766588235721 - 608 - Adhesive Bandages Plastic 2"x 3" - 6/unit2025-12-23 608 - Adhesive Bandages Plastic 2"x 3" - 6/unit
00766588160825 - 816 - Nitrile Gloves - 2 pr/unit2025-12-16 816 - Nitrile Gloves - 2 pr/unit
00766588190051 - QF Tape 1/2" x 2.5 yds. - Roll2025-12-16 QF Tape 1/2" x 2.5 yds. - Roll
00766588250083 - Safety General Purpose - 16 Poly White2025-12-16 Safety General Purpose - 16 Poly White
00766588069012 - Gillig Bus 24 - Refill2025-12-10 Gillig Bus 24 - Refill

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.