MemoFix Super Elastic Nitinol Staple System MS121916

GUDID 00885556827611

MEMOFIX NITINOL STAPLE 12MM X 19MM X 16MM

Smith & Nephew, Inc.

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 00885556827611
• NIH Device Record Key: 9476a65a-d8c1-4e4a-8be7-956169549d78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MemoFix Super Elastic Nitinol Staple System
• Version Model Number: MS121916
• Catalog Number: MS121916
• Company DUNS: 109903521
• 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: 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: 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
• 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	00885556827611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123926

FDA Product Code

• JDR: Staple, fixation, bone

Sterilization

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

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

[00885556827611]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-20
• Device Publish Date: 2023-02-10

On-Brand Devices [MemoFix Super Elastic Nitinol Staple System]

• 00885556827918: MEMOFIX REMOVAL TOOL
• 00885556827901: MEMOFIX PICKUP FORCEPS
• 00885556827895: MEMOFIX TAMP
• 00885556827710: MEMOFIX NITINOL STAPLE 25MM X 22MM X 22MM
• 00885556827703: MEMOFIX NITINOL STAPLE 25MM X 20MM X 20MM
• 00885556827697: MEMOFIX NITINOL STAPLE 20MM X 20MM X 20MM
• 00885556827680: MEMOFIX NITINOL STAPLE 20MM X 15MM X 15MM
• 00885556827673: MEMOFIX NITINOL STAPLE 18MM X 19MM X 17MM
• 00885556827666: MEMOFIX NITINOL STAPLE 18MM X 17MM X 15MM
• 00885556827659: MEMOFIX NITINOL STAPLE 18MM X 14MM X 14MM
• 00885556827642: MEMOFIX NITINOL STAPLE 18MM X 12MM X 12MM
• 00885556827635: MEMOFIX NITINOL STAPLE 15MM X 15MM X 15MM
• 00885556827628: MEMOFIX NITINOL STAPLE 15MM X 12MM X 12MM
• 00885556827611: MEMOFIX NITINOL STAPLE 12MM X 19MM X 16MM
• 00885556827604: MEMOFIX NITINOL STAPLE 12MM X 17MM X 15MM
• 00885556827598: MEMOFIX NITINOL STAPLE 12MM X 15MM X 13MM
• 00885556827581: MEMOFIX NITINOL STAPLE 12MM X 10MM X 10MM
• 00885556827574: MEMOFIX NITINOL STAPLE 10MM X 17MM X 15MM
• 00885556827567: MEMOFIX NITINOL STAPLE 10MM X 15MM X 13MM
• 00885556827550: MEMOFIX NITINOL STAPLE 10MM X 10MM X 10MM
• 00885556827543: MEMOFIX NITINOL STAPLE 8MM X 8MM X 8MM
• 00885556827956: MEMOFIX STAPLE STERILIZATION TRAY LID
• 00885556827949: MEMOFIX STAPLE STERILIZATION TRAY CADDY
• 00885556827932: STAPLE STERILIZATION INSTRUMENT TRAY LID
• 00885556827925: STAPLE STERILIZATION INSTRUMENT TRAY
• 00885556827888: MEMOFIX DRILL GUIDE
• 00885556827871: MEMOFIX 20.25MM STAPLE SPREADER
• 00885556827864: MEMOFIX 15. 18MM STAPLE SPREADER
• 00885556827857: MEMOFIX 8.10.12MM STAPLE SPREADER
• 00885556827840: MEMOFIX DRILL STOP ADAPTERS 22MM
• 00885556827833: MEMOFIX DRILL STOP ADAPTERS 19/20MM
• 00885556827826: MEMOFIX DRILL STOP ADAPTERS 16/17MM
• 00885556827819: MEMOFIX DRILL STOP ADAPTERS 14/15MM
• 00885556827802: MEMOFIX DRILL STOP ADAPTERS 12/13MM
• 00885556827796: MEMOFIX DRILL STOP ADAPTERS 10MM
• 00885556827789: MEMOFIX DRILL STOP ADAPTERS 8MM
• 00885556827772: MEMOFIX PIN 2.7MM
• 00885556827765: MEMOFIX PIN 2.0MM
• 00885556827758: MEMOFIX PIN 1.7MM
• 00885556827741: MEMOFIX DRILL BIT 2.7MM
• 00885556827734: MEMOFIX DRILL BIT 2.0MM
• 00885556827727: MEMOFIX DRILL BIT 1.7MM