111416

GUDID 03596010038791

COMBINATION MALLET 20 OZ

Smith & Nephew, Inc.

Surgical mallet

• Primary Device ID: 03596010038791
• NIH Device Record Key: 397d99dd-e03a-4477-b56e-03dcb27e7a6e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111416
• Catalog Number: 111416
• Company DUNS: 045483575
• Company Name: Smith & Nephew, 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: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010038791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

[03596010038791]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556922194 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 9MM
• 00885556922217 - LEGION: 2025-04-15 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK LEFT SZ 1-2 10MM
• 00885556905470 - NA: 2025-03-12 VARIABLE ANGLE VALGUS GUIDE
• 00885556880876 - EVOS: 2025-02-28 EVOS 2.7MM STAGGERED PATELLA PLATE
• 00885556880883 - EVOS: 2025-02-28 EVOS 2.7MM SPLIT PATELLA PLATE
• 00885556886403 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - SMALL
• 00885556886410 - EVOS: 2025-02-28 EVOS 2.7MM MESH PATELLA PLATE - LARGE
• 23596010587682 - FOOTPRINT: 2025-01-10 REPLACEMENT END CAPS FOR MALLET SET OF 2