FDA UDI
In Commercial Distribution
🇺🇸 United States
Drill little AO coupling Ø3 x 146 mm
DI: 07640187914184
·
Model: T882
·
MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Drill little AO coupling Ø3 x 146 mm
- Primary DI
- 07640187914184
- Version / Model
- T882
- Catalog Number
- T882
- Company Name
- MPS Micro Precision Systems AG
- Labeler DUNS
- 482204059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-11
- Public Version
- 2
- Public Version Date
- 2022-11-18
- Public Version Status
- Update
- Public Device Record Key
- f4837b1b-8cc5-4c45-b28e-0d82b3a959ca
Device Description
The drills with or without coupling for attachment to a power tool are re-usable rotary cutting instruments used in surgery for drilling cylindrical holes into bone. The cutting action is determined by the cutting edges.Two kind of coupling, permitting the connection with the power tool, exist: an AO coupling or a chuck coupling. A range of diameter and length is proposed.The drills are used with a power tool.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTW | Bit, Drill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32390 | Fluted surgical drill bit, reusable | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640187914184 | GS1 |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]