FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10885862553003
·
Model: 01-007-04-4530
·
Exactech, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10885862553003
- Version / Model
- 01-007-04-4530
- Catalog Number
- 01-007-04-4530
- Company Name
- Exactech, Inc.
- Labeler DUNS
- 157565946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-18
- Public Version
- 1
- Public Version Date
- 2022-08-26
- Public Version Status
- New
- Public Device Record Key
- 5226173a-79be-4f42-bd2a-2e2c9a1bdba2
Device Description
ART DRILL DRVR, 4.5X30MM
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | Orthopedic | 888.3565 | 2 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Orthopedic | 888.3560 | 2 |
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 | 10885862553003 | GS1 |
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Millimeter | |
| Device Size Text, specify | Drill Length | ||
| Device Size Text, specify | Drill Diameter | ||
| Outer Diameter | 4.5 | Millimeter |