FDA UDI
In Commercial Distribution
🇺🇸 United States
SportsMed Instruments
DI: 07630345752659
·
Model: 05.05.10.0191
·
Medacta International SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SportsMed Instruments
- Primary DI
- 07630345752659
- Version / Model
- 05.05.10.0191
- Company Name
- Medacta International SA
- Labeler DUNS
- 488227125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-25
- Public Version
- 1
- Public Version Date
- 2022-05-03
- Public Version Status
- New
- Public Device Record Key
- 8a943ff7-1766-48bf-8dea-c401901403e5
Device Description
Low Profile Reamer Ø7.5mm STERILE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBH | Accessories, Arthroscopic | Orthopedic | 888.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44090 | Arthroscopic surgical procedure kit, medicated | A collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform an arthroscopic surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630345752659 | GS1 |