Identity
- Trade Name
- Diamond Needle (1) Pkg FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Model / Reference
- N-81002R FDA UDI
Identifiers
- Catalog Number
- N-81002R FDA UDI
- Primary DI / UDI-DI
- D757N81002R1 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Diamond Needle (1) Pkg by Bisco Inc. — 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
- Bisco Inc.
Sources (1)
- FDA UDI baf597d2-af0e-4df3-ab3d-eb2dbf1b0151 36 fields · synced Jun 8, 2026