ULTRABRACE 72205500

GUDID 00885556890752

ULTRABRACE 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

• Primary Device ID: 00885556890752
• NIH Device Record Key: 82e859de-c44d-4546-b06e-fdb9d8110b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRABRACE
• Version Model Number: 72205500
• Catalog Number: 72205500
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556890752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232457

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

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: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by Smith & Nephew, Inc.

• 00885556887165 - PLATINUM: 2024-05-27 PLATINUM MDU BF
• 00885556919033 - R3: 2024-05-24 R3 ANTI-ROTATION TIP W/FLAT SZ58MM
• 00885556918616 - R3: 2024-05-23 SHORT OFFSET ACETABULAR IMPACTOR
• 00885556918623 - R3: 2024-05-23 SZ 42MM BRIDGEBACK REAMER
• 00885556918630 - R3: 2024-05-23 SZ 44MM BRIDGEBACK REAMER
• 00885556918647 - R3: 2024-05-23 SZ 46MM BRIDGEBACK REAMER
• 00885556918654 - R3: 2024-05-23 SZ 48MM BRIDGEBACK REAMER
• 00885556918661 - R3: 2024-05-23 SZ 50MM BRIDGEBACK REAMER