RELIGN

GUDID B504ASR100120

Provision

Arthroscopic shaver system blade, reprocessed

• Primary Device ID: B504ASR100120
• NIH Device Record Key: 3a027b6d-73e9-45ab-84ae-973f5f08fef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIGN
• Version Model Number: R-10012
• Company DUNS: 016889401
• Company Name: Provision
• Device Count: 1
• DM Exempt: true
• 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: 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: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com
• Phone: 541-422-8880
• Email: mark@provisiondrs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 7 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B504ASR100120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172092

FDA Product Code

• HRX: Arthroscope

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: 2024-07-09
• Device Publish Date: 2024-07-01

On-Brand Devices [RELIGN]

• B504ASR100120: R-10012
• B504ABR100210: R-10021