Kompressor 2804014A

GUDID 00885556868942

REAR FOOT RECONSTRUCTION PLATE, 66MM, 14 HOLES

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00885556868942
• NIH Device Record Key: bf2dcadc-bbfb-4616-a84d-3955131b1310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kompressor
• Version Model Number: 2804014
• Catalog Number: 2804014A
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556868942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100502

FDA Product Code

• HRS: Plate, fixation, bone
• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

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[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

[00885556868942]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-18

On-Brand Devices [Kompressor]

• 00885556868966: DEPTH GAGE, FIXED ANGLE SURFIX, DIAMETER 3.5 MM
• 00885556868942: REAR FOOT RECONSTRUCTION PLATE, 66MM, 14 HOLES
• 00885556869062: MINI K-WIRE 0.9MM