AlloWedge 55-DISTRACTOR

GUDID 00191083047393

Distractor, Foot and Ankle Wedge

Rti Surgical, Inc.

Orthopaedic surgical distractor, external

• Primary Device ID: 00191083047393
• NIH Device Record Key: a709a08d-c17a-4d0e-b156-b07c0a1bcfc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlloWedge
• Version Model Number: 55-DISTRACTOR
• Catalog Number: 55-DISTRACTOR
• Company DUNS: 117560455
• Company Name: Rti Surgical, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083047393 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

[00191083047393]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [AlloWedge]

• 00191083047416: Sterilization Case
• 00191083047409: Distractor, Narrow, Foot and Ankle Wedge
• 00191083047393: Distractor, Foot and Ankle Wedge
• 00191083047386: Mallet - Foot and Ankle Wedge
• 00191083047379: EVANS TRIAL ASSEMBLY, 12mm
• 00191083047362: EVANS TRIAL ASSEMBLY, 10mm
• 00191083047355: EVANS TRIAL ASSEMBLY, 8mm
• 00191083047348: EVANS TRIAL ASSEMBLY, 6mm
• 00191083047331: COTTON TRIAL ASSEMBLY, 8mm
• 00191083047324: COTTON TRIAL ASSEMBLY, 7mm
• 00191083047317: COTTON TRIAL ASSEMBLY, 6mm
• 00191083047300: COTTON TRIAL ASSEMBLY, 5mm
• 00191083047294: OSTEOTOME, FOOT AND ANKLE
• 00191083047287: SMALL TAMP, FOOT AND ANKLE
• 00191083047270: LARGE TAMP, FOOT AND ANKLE