111127

GUDID 03596010037824

STAPLE HAMMER

Smith & Nephew, Inc.

Surgical mallet

• Primary Device ID: 03596010037824
• NIH Device Record Key: e47c8160-e720-4683-b8da-8b1400d4e601
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111127
• Catalog Number: 111127
• 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	03596010037824 [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

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

Moist Heat or Steam Sterilization

[03596010037824]

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

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• 00885556891629 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 6
• 00885556891735 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 4
• 00885556891742 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED HIGH OFFSET SIZE 5
• 00885556891759 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
• 00885556892107 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 0
• 00885556892114 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 1