ULTRABRIDGE 72205700

GUDID 00885556885628

ULTRABRIDGE KIT

Smith & Nephew, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00885556885628
• NIH Device Record Key: 2e588eb0-facf-4960-91c1-0dc9e437fddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRABRIDGE
• Version Model Number: 72205700
• Catalog Number: 72205700
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556885628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232005

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-29
• Device Publish Date: 2024-01-21

On-Brand Devices [ULTRABRIDGE]

• 00885556885628: ULTRABRIDGE KIT
• 00885556885574: ULTRABRIDGE DRILL 4.0MM