Ambi/Classic XT001031-1

GUDID 00885556654293

INTRMED PLT 100 DEG 3H W/ 4MM OFFSET

Smith & Nephew, Inc.

Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00885556654293
• NIH Device Record Key: ded22ceb-3bbf-4675-b3a9-7a24d3698a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambi/Classic
• Version Model Number: XT001031-1
• Catalog Number: XT001031-1
• 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: true
• 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
• 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	00885556654293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993289

FDA Product Code

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

Sterilization

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

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

Moist Heat or Steam Sterilization

[00885556654293]

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: 2016-06-24

On-Brand Devices [Ambi/Classic]

• 00885556654309: INTRMED PLT 110 DEG 3H W/ 4MM OFFSET
• 00885556654293: INTRMED PLT 100 DEG 3H W/ 4MM OFFSET