FDA UDI
In Commercial Distribution
🇺🇸 United States
Cordera Hip System Offset Reamer Driver, Enztec
DI: 00810933031107
·
Model: 1080-645
·
Conformis, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cordera Hip System Offset Reamer Driver, Enztec
- Primary DI
- 00810933031107
- Version / Model
- 1080-645
- Catalog Number
- 1080-645
- Company Name
- Conformis, Inc.
- Labeler DUNS
- 808821883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-07
- Public Version
- 1
- Public Version Date
- 2022-03-15
- Public Version Status
- New
- Public Device Record Key
- a46b5f12-0009-4a76-9425-ff2d11771327
Device Description
Offset Reamer Driver, Enztec
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
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
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 |
|---|---|---|---|---|---|---|
| Direct Marking | 09421028113274 | GS1 | ||||
| Primary | 00810933031107 | GS1 |
Customer Contacts
- Phone
- 781-345-9001
- [email protected]