Identity
- Trade Name
- Bone Reamer Brushes FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
- Device Name
- Bone Reamer Brush, Nylon bristles, stainless steel handle, .118-inch diam, 31-inch long, 3 per package FDA UDI
- Model / Reference
- BR-31-118 FDA UDI
- Description
- Bone Reamer Brush, Nylon bristles, stainless steel handle, .118-inch diam, 31-inch long, 3 per package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849771031659 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 31 Inch FDA UDIOuter Diameter — .118 Inch FDA UDI
Bone Reamer Brushes by Key Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Key Surgical, LLC
Sources (1)
- FDA UDI a737fbf6-b524-44aa-8283-b9cd2f8dc088 36 fields · synced May 30, 2026