← Back to catalogue
DRILL BIT D3, 0 mm L=145/50 mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref T16936Model Drill bits
by Hpf Srl
Identity
- Trade Name
- BOR D3,0 mm EUDAMEDDRILL BIT D3,0 mm L=145/50 mm FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Model / Reference
- T16936 EUDAMEDFDA UDIDrill bits EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055727370754 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08055727370754 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Fluted surgical drill bit, reusable
DRILL BIT D3, 0 mm L=145/50 mm by Hpf Srl — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hpf Srl
Sources (2)
- FDA UDI 405139aa-5cc0-49ef-af69-3a0faf77dbfd 32 fields · synced Jul 13, 2026
- EUDAMED f45d6616-81d4-4615-9d82-615b26b84b27 61 fields · synced Jul 13, 2026