634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit R211-024

GUDID 00766588110240

634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit

Certified Safety Manufacturing, Inc.

Non-woven gauze roll/sheet

• Primary Device ID: 00766588110240
• NIH Device Record Key: 8b3b8d87-a9e5-42b6-ad69-4319db85ff1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 634 - Certi-Gauze Roll - 2" x 6 yards - 2/Unit
• Version Model Number: R211-024
• Catalog Number: R211-024
• 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	00766588110240 [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.

• 00766588110110 - 637 - Certi-Gauze Pads - 3"x 3" - 4/Unit: 2024-11-07 637 - Certi-Gauze Pads - 3"x 3" - 4/Unit
• 00766588110141 - 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit: 2024-11-07 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit
• 00766588110172 - 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit: 2024-11-07 639 - Certi-Gauze Compress - 36"x 36" - 1/Unit
• 00766588110219 - 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit: 2024-11-07 640 - Certi-Gauze Compress - 24"x 72" - 1/Unit
• 00766588110301 - 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit: 2024-11-07 628 - Certi-Non-Stick Pads - 2"x 3" - 4/Unit
• 00766588310039 - Certi-Non Stick Pads - 2"x 3" - 25/Box: 2024-11-07 Certi-Non Stick Pads - 2"x 3" - 25/Box
• 00766588312057 - Certi-Gauze Pads - 3"x 3" - 100/Box: 2024-11-07 Certi-Gauze Pads - 3"x 3" - 100/Box
• 00766588312095 - Certi-Gauze Pads - 2"x 2" - 25/Box: 2024-11-07 Certi-Gauze Pads - 2"x 2" - 25/Box