RemeOs Instrument

GUDID 06438394012981

Bioretec Oy

Surgical screwdriver, reusable

• Primary Device ID: 06438394012981
• NIH Device Record Key: 2e36bb78-efef-4d6e-b4dd-16fd50d06995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RemeOs Instrument
• Version Model Number: B-IRC-4002
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438394012981 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

[06438394012981]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [RemeOs Instrument]

• 06438394012981: B-IRC-4002
• 06438394015777: Sterilization Insert, for RemeOs™ Instruments
• 06438394015760: Sterilization Base and Lid, for Sterilization Inserts