FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Affiniti
DI: 00846832024797
·
Model: 9000448
·
TORNIER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Affiniti
- Primary DI
- 00846832024797
- Version / Model
- 9000448
- Catalog Number
- 9000448
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-09
- Public Version
- 2
- Public Version Date
- 2023-10-11
- Public Version Status
- Update
- Public Device Record Key
- 3e1d09a2-88bd-4d67-bb9f-bb0eecf8280f
- Distribution End Date
- 2022-11-01
Device Description
GLENOID 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
- Yes
- 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 |
|---|---|---|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60927 | Glenoid orthopaedic reamer | An orthopaedic surgical instrument designed to cut and resurface with precision the glenoid fossa for the acceptance of the glenoid fossa component of a shoulder joint prosthesis. The device is designed with a hemispherical head with an abrasive/cutting outer surface attached to a shaft for connection to a manual or powered handle. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846832024797 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 48 |