BioBrush DDBK02

GUDID 00850011453285

BioBrush Powered Debridement Device (Large Brush)

OSTEOREMEDIES, LLC

Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system Arthroscopic shaver/electrosurgical system

• Primary Device ID: 00850011453285
• NIH Device Record Key: cda3b514-9d63-4fe8-992d-feede29d6599
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBrush
• Version Model Number: DDBK02
• Catalog Number: DDBK02
• Company DUNS: 079596704
• Company Name: OSTEOREMEDIES, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011453285 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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: 2024-01-05
• Device Publish Date: 2023-12-28

Devices Manufactured by OSTEOREMEDIES, LLC

• 00850011453285 - BioBrush: 2024-01-05BioBrush Powered Debridement Device (Large Brush)
• 00850011453285 - BioBrush: 2024-01-05 BioBrush Powered Debridement Device (Large Brush)
• 00850011453278 - Remedy Spacer: 2023-09-18 REMEDY® Stemmed Knee - Adjunct Base
• 00850011453230 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Component 150, 13/11 OD
• 00850011453247 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Component 230, 13/11 OD
• 00850011453254 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Trial 150, 13/11 OD
• 00850011453261 - Remedy Spacer: 2023-06-08 REMEDY® Stem Extension Trial 230, 13/11 OD
• 00850011453001 - Remedy Spacer: 2022-12-13 REMEDY® RADEL® Humeral Head Trial 40mm
• 00850011453018 - Remedy Spacer: 2022-12-13 REMEDY® RADEL® Humeral Head Trial 45mm