FDA UDI
In Commercial Distribution
🇺🇸 United States
Stainless steel 90-degree swivel barb
DI: 00850013242276
·
Model: CA300-B90
·
CYPRESS ADAPTIVE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stainless steel 90-degree swivel barb
- Primary DI
- 00850013242276
- Version / Model
- CA300-B90
- Catalog Number
- CA300-B90
- Company Name
- CYPRESS ADAPTIVE, LLC
- Labeler DUNS
- 080277500
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-17
- Public Version
- 2
- Public Version Date
- 2021-08-12
- Public Version Status
- Update
- Public Device Record Key
- 6679da77-26d1-4403-ab45-d141d4f71e64
Device Description
Swivel barb 90-degree for installation into prosthetic sockets
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| ISP | Valve, Prosthesis | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64715 | External lower-limb prosthesis suspensory component, non-powered | A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850013242276 | GS1 |