Subtalar MBA Implant System 055001

GUDID 00885556866047

MBA TRAY STERILIZATION CASE

Smith & Nephew, Inc.

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00885556866047
• NIH Device Record Key: 40caa584-63b7-4be5-9f87-77f29bcbac53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Subtalar MBA Implant System
• Version Model Number: 055001
• Catalog Number: 055001
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00885556866047 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

[00885556866047]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [Subtalar MBA Implant System]

• 00885556866047: MBA TRAY STERILIZATION CASE
• 00885556866030: DRIVER FOR TITANIUM MBA ONLY 3.5MM HRX
• 00885556866023: 12MM SIZER
• 00885556866016: 10MM SIZER
• 00885556866009: 9MM SIZER
• 00885556865996: 8MM SIZER
• 00885556865989: 6MM SIZER
• 00885556865972: PROBE
• 00885556821671: COMBO DRIVER
• 00885556865910: SUBTALAR MBA IMPLANT. 12MM
• 00885556865903: SUBTALAR MBA IMPLANT. 10MM
• 00885556865897: SUBTALAR MBA IMPLANT. 9MM
• 00885556865880: SUBTALAR MBA IMPLANT. 8MM
• 00885556865873: SUBTALAR MBA IMPLANT. 6MM