FDA UDI
In Commercial Distribution
🇺🇸 United States
NEOPRENE TENNIS ELBOW LONG
DI: 50610570187510
·
Model: 90001531
·
Bird & Cronin, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- NEOPRENE TENNIS ELBOW LONG
- Primary DI
- 50610570187510
- Version / Model
- 90001531
- Company Name
- Bird & Cronin, LLC
- Labeler DUNS
- 045975349
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-08-30
- Public Version
- 1
- Public Version Date
- 2022-09-07
- Public Version Status
- New
- Public Device Record Key
- db0ee9cc-65ba-4b97-9d8c-2545028d14fa
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQI | Orthosis, Limb Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41053 | Elbow orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50610570187510 | GS1 | ||||
| Unit of Use | 00610570187515 | GS1 |