FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTRUMENT
DI: 00848486027889
·
Model: 2102-0449
·
Howmedica Osteonics Corp.
Product Codes
11
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INSTRUMENT
- Primary DI
- 00848486027889
- Version / Model
- 2102-0449
- Catalog Number
- 2102-0449
- Company Name
- Howmedica Osteonics Corp.
- Labeler DUNS
- 058311945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-01-13
- Public Version Status
- Update
- Public Device Record Key
- d7c7e597-90b3-438c-8f18-54c9ebc662bf
Device Description
CUTTING EDGE ACETABULAR SPHERICAL REAMER
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 |
|---|---|---|---|---|
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented | Orthopedic | 888.3390 | 2 |
| KWL | Prosthesis, hip, hemi-, femoral, metal | Orthopedic | 888.3360 | 2 |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented | Orthopedic | 888.3360 | 2 |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish | Orthopedic | 888.3353 | 2 |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous | Orthopedic | 888.3358 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate | Orthopedic | 888.3353 | 2 |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer | Orthopedic | 888.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32848 | Acetabular orthopaedic reamer | An orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848486027889 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 49.0 Millimeter |