635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit R211-027

GUDID 00766588110271

635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit

Certified Safety Manufacturing, Inc.

Non-woven gauze roll/sheet

• Primary Device ID: 00766588110271
• NIH Device Record Key: 032025d8-8198-4711-b408-72b52df8ac51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 635 - Certi-Gauze Roll - 4" x 6 yards - 1/Unit
• Version Model Number: R211-027
• Catalog Number: R211-027
• Company DUNS: 788460483
• Company Name: Certified Safety Manufacturing, Inc.
• Device Count: 1
• 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: 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: false

Customer Support Contacts

• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com
• Phone: +1(816)483-9090
• Email: Info@certifiedsafety.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766588110271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945002

FDA Product Code

• EFQ: GAUZE/SPONGE, INTERNAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-01-27

Devices Manufactured by Certified Safety Manufacturing, Inc.

• 00766588042053 - New Mexico SBK - 24 Poly White: 2025-08-29 New Mexico SBK - 24 Poly White
• 00766588089560 - Mississippi BFK - Refill: 2025-08-29 Mississippi BFK - Refill
• 00766588089577 - North Carolina BFK 10 Refill: 2025-08-29 North Carolina BFK 10 Refill
• 00766588120843 - PG&E - 10 Poly White: 2025-08-29 PG&E - 10 Poly White
• 00766588139401 - Heat Stress Relief - 16 Refill: 2025-08-29 Heat Stress Relief - 16 Refill
• 00766588179070 - Norfolk Southern - 16 Refill: 2025-08-29 Norfolk Southern - 16 Refill
• 00766588226057 - PH - Cramer B4 Trainer Kit - 111100 - CB977: 2025-08-29 PH - Cramer B4 Trainer Kit - 111100 - CB977
• 00766588250106 - Heat Stress - 16 Poly White: 2025-08-29 Heat Stress - 16 Poly White