013569

GUDID 03596010091161

RASP TNL BONE

Smith & Nephew, Inc.

Bone file/rasp, manual

• Primary Device ID: 03596010091161
• NIH Device Record Key: b17a27f1-4a67-40ad-96cc-5b542f4a4f9d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 013569
• Catalog Number: 013569
• 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)821-5700
• 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
• 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	03596010091161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940985

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

[03596010091161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

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• 00885556919613 - R3: 2024-11-12 OFFSET CUP IMPACTOR
• 00885556000908 - Legion: 2024-11-05 1 Degree Varus/Valgus Recut Block
• 00885556000915 - Legion: 2024-11-05 2 Degree Varus/Valgus Recut Block
• 00885556920640 - NA: 2024-11-05 4.5mm Proximal Tibia Plate 4 Hole EVOS
• 00885556920831 - Legion: 2024-11-05 Monolithic CR DF Trial Sz 3-4 - 18mm