283556

GUDID 03596010463937

POLOKOFF RASP 203MM DOUBLE ENDED DOWNCUTTING

Smith & Nephew, Inc.

Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable

• Primary Device ID: 03596010463937
• NIH Device Record Key: 70681e04-a433-47dd-95a5-a25f2e5e7843
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 283556
• Catalog Number: 283556
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010463937 [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

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

[03596010463937]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

• 00885556902738 - INTELLIO SHIFT: 2024-05-15 NEO CONTROLLER REFURBISH
• 00885556630761 - Q-FIX: 2024-05-14 DISPOSABLE 1.8MM Q-FIX DRILL
• 00885556630785 - Q-FIX: 2024-05-14 REUSABLE 1.8MMQ-FIX DRILL GUIDE
• 00885556918333 - R3: 2024-05-10 FEMORAL OSTEOTOMY RULER
• 00885556817667 - TULA: 2024-05-07 TULA KIT- UNILATERAL (NST007068)
• 00885556890745 - Q-FIX: 2024-05-06 Q-FIX ULTRA
• 00885556890752 - ULTRABRACE: 2024-05-06 ULTRABRACE KIT
• 00885556890769 - FOOTPRINT: 2024-05-06 FOOTPRINT MINI PK 3.5MM