210064

GUDID 03596010101723

SUPER-BITE PIN CUTTER

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03596010101723
• NIH Device Record Key: 28d11c1c-1512-4268-87ea-9c8a4410d6a2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210064
• Catalog Number: 210064
• 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: 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
• 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	03596010101723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093047

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

[03596010101723]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556903414 - EVOS: 2025-09-04 EVOS PELVIC 5.0MM X 130MM CANNULATED SCREW FULLY THREADED
• 00885556924761 - CORIOGRAPH: 2025-08-27 CORIOGRAPH Shoulder Pre-Operative Planning and Modeling Services V1.0. Modules in scope: CORIOGRAPH Shoulder Pre-Op Plan CORIOGR
• 00885556538418 - Legion: 2025-07-25 LEGION FINNED TIBIAL WEDGE SIZE4 20MM LEFT
• 00885556538401 - Legion: 2025-07-23 LEGION FINNED TIBIAL WEDGE SIZE4 15MM LEFT
• 00885556915875 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
• 00885556915882 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
• 00885556915899 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
• 00885556915905 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST