Identity
- Trade Name
- MSI FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- Hudson Drill Set Complete Includes: Extension Piece, Hudson Burr - 9mm, Huson Burr - 14mm, Hudson Burr - 16mm, Hudson Burr - 22mm, Cushing Drill Bit - 14mm, Drill Bit - 2mm, McKenzie Drill Bit - 13mm, D'Errico Drill Bit - 16mm FDA UDI
- Model / Reference
- 48-0464 FDA UDI
- Description
- Hudson Drill Set Complete Includes: Extension Piece, Hudson Burr - 9mm, Huson Burr - 14mm, Hudson Burr - 16mm, Hudson Burr - 22mm, Cushing Drill Bit - 14mm, Drill Bit - 2mm, McKenzie Drill Bit - 13mm, D'Errico Drill Bit - 16mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810130206940 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Category: Manual surgical rotary handpiece, reusable
Msi by Modern Surgical Instruments LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual surgical rotary handpiece, reusable.
- RENOIR Posterior Cervico-Thoracic Fixation System — CTL Medical Corporation · Class I
- MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO — W.H. Holden, Inc. · Class I
- Invivo — Philips DS North America LLC · Class II
- GII — Medos International Sàrl · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- HALLMARK — Orthofix US LLC · Class I
- CHESAPEAKE Stabilization System — K2M, INC. · 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
- Modern Surgical Instruments LLC
Sources (1)
- FDA UDI be0bf55b-3c4b-4467-8692-150df58d6012 33 fields · synced May 30, 2026