210020

GUDID 00885556009321

LEWIN CLAMP STAINLESS STEEL 25.4MM

Smith & Nephew, Inc.

Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp Bone approximation clamp

• Primary Device ID: 00885556009321
• NIH Device Record Key: ebeebd3f-fa46-48b7-b340-e8ed0685ffec
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 210020
• Catalog Number: 210020
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556009321 [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

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

[00885556009321]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

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• 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