FDA UDI
In Commercial Distribution
🇺🇸 United States
BioBrush
DI: 00850011453223
·
Model: DDBK03
·
OSTEOREMEDIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BioBrush
- Primary DI
- 00850011453223
- Version / Model
- DDBK03
- Catalog Number
- DDBK03
- Company Name
- OSTEOREMEDIES, LLC
- Labeler DUNS
- 079596704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-20
- Public Version
- 1
- Public Version Date
- 2026-04-28
- Public Version Status
- New
- Public Device Record Key
- a07871ba-37ca-4de9-aafc-e8e9bd9a339f
Device Description
BioBrush Disposable Debridement Brush Small 24 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52528 | Arthroscopic shaver/electrosurgical system | An assembly of mains electricity (AC-powered) devices designed to perform arthroscopic shaving (i.e., abrasion, resection, debridement of bone and soft tissue with a blade) and electrosurgical diathermy (i.e., the ablation and coagulation of soft tissue, as well as haemostasis of blood vessels, with an electrosurgical probe) during arthroscopic procedures on a joint. It typically consists of a combination shaver/electrosurgical generator with operational display and software to help provide optimal parameters for the shaver handpiece(s) to operate a variety of burs/blades and electrosurgical probes, tips, and cables. An irrigation system may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011453223 | GS1 |