ALLEN
- Primary DI
- 00615521015367
- Brand
- ALLEN
- Company
- ALLEN MEDICAL SYSTEMS, INC.
- Model
- 102006
- Catalog number
- F-UC4UK
- Device description
- Uro Catcher System UK Rail
- Published
- 2023-05-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| NNW | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00615521015367 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00615521015367 | 00615521015367 | 615521015367 | 0615521015367 |
GMDN Terms
| Term | Definition |
|---|
| Urological fluid funnel, non-sterile | A non-sterile device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device. |
Regulatory Flags
- DUNS number
- 147805894
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
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|---|
| 00860012266807 | Acosta Uro-Gard | Acosta Medical Group, Inc. | NNW | 2025-02-19 |
| 10860012266811 | Acosta Uro-Gard | Acosta Medical Group, Inc. | NNW | 2025-02-19 |
| 00618125191185 | TIDIShield | TIDI PRODUCTS, LLC | NNW | 2024-04-05 |
| 15060797553860 | NA | David Scott Company | NNW | 2023-07-26 |
| 00615521015336 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521015350 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521019990 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521020002 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521020019 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521020606 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
| 00615521020675 | ALLEN | ALLEN MEDICAL SYSTEMS, INC. | NNW | 2023-05-26 |
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| 20610075093421 | Hollister | HOLLISTER INCORPORATED | NNW | 2022-12-01 |
| 20610075093438 | Hollister | HOLLISTER INCORPORATED | NNW | 2022-12-01 |
| 20610075093452 | Hollister | HOLLISTER INCORPORATED | NNW | 2022-12-01 |
| 20610075093483 | Hollister | HOLLISTER INCORPORATED | NNW | 2022-12-01 |
| 20610075093490 | Hollister | HOLLISTER INCORPORATED | NNW | 2022-12-01 |
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| 05708932539258 | Conveen Security+ | Coloplast A/S | NNW | 2022-03-11 |
| 05708932539289 | Conveen Security+ | Coloplast A/S | NNW | 2022-03-11 |