GUHL/ACUFEX 6905009

GUDID 00885554008258

MTO BAR SUPPORT GUHL ANKLE DISTRACTOR

Smith & Nephew, Inc.

Leg procedure positioner

• Primary Device ID: 00885554008258
• NIH Device Record Key: 7a6c27a2-b23e-4c81-b63e-76e4499273c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUHL/ACUFEX
• Version Model Number: 6905009
• Catalog Number: 6905009
• 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: 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: false
• OTC Over-The-Counter: true

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
• 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	00885554008258 [Primary]

FDA Product Code

• KQZ: COMPONENT, TRACTION, NON-INVASIVE

Sterilization

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

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

[00885554008258]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-04-12

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556896518 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 40MM
• 00885556896525 - NA: 2025-05-13 TRIGEN MAX 5.0MM LAG SCREW - 42.5MM
• 00885556898994 - NA: 2025-05-13 TRIGEN MAX 20MM SPIKED WASHER
• 00885556921562 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 11MM
• 00885556921579 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
• 00885556921586 - LEGION: 2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM