FDA UDI
In Commercial Distribution
🇺🇸 United States
GU Tek
DI: 00850005780168
·
Model: UCA5-95
·
V L V ASSOCIATES (INC)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GU Tek
- Primary DI
- 00850005780168
- Version / Model
- UCA5-95
- Catalog Number
- UCA5-95
- Company Name
- V L V ASSOCIATES (INC)
- Labeler DUNS
- 118877356
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-15
- Public Version
- 1
- Public Version Date
- 2020-07-23
- Public Version Status
- New
- Public Device Record Key
- 4d33c617-ca4b-4ff7-9d7a-2267895d3291
Device Description
Ureteral Catheter Connecting Adapter
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EYK | Connector, Ureteral Catheter | Gastroenterology, Urology | 876.5130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64695 | Ureteral/urethral catheter multichannel external connector | A small, non-powered, noninvasive, small-bore, tubular connector, with three or more connections that are non-ISO80369-standardized, intended to connect both a urethral catheter and a ureteral catheter(s) to tubing during a drainage procedure. It does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005780168 | GS1 |