Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Manual bone mill FDA UDI
- Device Name
- T842 Titanium Bone Cracker (40mm dia.) FDA UDI
- Model / Reference
- T842 Titanium Bone Cracker (40mm dia.) FDA UDI
- Description
- T842 Titanium Bone Cracker (40mm dia.) FDA UDI
Identifiers
- Catalog Number
- T842 FDA UDI
- Primary DI / UDI-DI
- 00813677023582 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Manual bone mill FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- 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
Category: Manual bone mill
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual bone mill.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- BONE MILL SET — SONTEC INSTRUMENTS, INC. · Class I
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- BONE MILL — KLS-Martin L.P. · Class I
- BONE GRINDER — SONTEC INSTRUMENTS, INC. · Class I
- Milling Drum Extra Extra Coarse — Spierings Orthopaedics B.V. · Class I
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PDT, Inc.
Sources (1)
- FDA UDI 59c62092-a72e-4d65-96e8-6b5a0298571d 34 fields · synced Jun 9, 2026