Avalign

GUDID B504OM8532421270

Provision

Drilling power tool attachment, basic

• Primary Device ID: B504OM8532421270
• NIH Device Record Key: ee31928a-b3ad-45e0-889f-5edfeaf4c195
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalign
• Version Model Number: 85-3242127
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• 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: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com
• Phone: 541-480-7953
• Email: customersupport@provisiondrs.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504OM8532421270 [Primary]

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by Provision

• B504CBEIC9820010 - Smith & Nephew: 2024-07-23
• B504ABR100210 - RELIGN: 2024-07-09
• B504ASR100120 - RELIGN: 2024-07-09
• B504CB1381050 - ConMed: 2024-07-09
• B504GS02065460000 - Stryker: 2024-07-09
• B504GS33501G0 - Cooper Surgical: 2024-07-09
• B504GS858640 - Medtronic: 2024-07-09
• B504OM0024GP2400 - Maruho Medical: 2024-07-09