POWERFLEX
- Primary DI
- 20705032047378
- Brand
- POWERFLEX
- Company
- CORDIS CORPORATION
- Model
- SRA0164
- Catalog number
- SRA0164
- Device description
- LONG SHEATH 7 F 70CM SHAPED
- Published
- 2016-08-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DYB | INTRODUCER, CATHETER |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K984500 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20705032047378 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20705032047378 | 20705032047378 |
GMDN Terms#
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not use if package is damanged |
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 806136177
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10705032019057 | VISTA BRITE TIP | 598941P | 598941P | 2024-02-23 |
| 10705032019170 | VISTA BRITE TIP | 598949P | 598949P | 2024-02-23 |
| 10705032020138 | VISTA BRITE TIP | 67004800 | 67004800 | 2024-02-23 |
| 10705032042956 | VISTA BRITE TIP | SM7497 | SM7497 | 2024-02-23 |
| 10705032043069 | VISTA BRITE TIP | SM7540 | SM7540 | 2024-02-23 |
| 10705032043144 | VISTA BRITE TIP | SM7548 | SM7548 | 2024-02-23 |
| 10705032043151 | VISTA BRITE TIP | SM7549 | SM7549 | 2024-02-23 |
| 10705032043434 | VISTA BRITE TIP | SM7596 | SM7596 | 2024-02-23 |
| 10705032043779 | VISTA BRITE TIP | SM7652 | SM7652 | 2024-02-23 |
| 10705032047050 | VISTA BRITE TIP | SRA0002IG | SRA0002IG | 2024-02-23 |
| 10705032047135 | VISTA BRITE TIP | SRA0016IG | SRA0016IG | 2024-02-23 |
| 10705032056625 | ATW Marker Wire Steerable Guidewires | 595MEJ014 | 595MEJ014 | 2021-01-26 |
| 20705032064863 | VISTA BRITE TIP | SM7732 | SM7732 | 2024-02-23 |
| 20705032064870 | VISTA BRITE TIP | SM7733 | SM7733 | 2024-02-23 |
| 20705032064887 | VISTA BRITE TIP | SM7731 | SM7731 | 2024-02-23 |
| 20705032065143 | VISTA BRITE TIP | SM7737 | SM7737 | 2024-02-23 |
| 10705032017169 | VISTA BRITE TIP | 588823E | 588823E | 2016-08-01 |
| 10705032017268 | VISTA BRITE TIP | 588830E | 588830E | 2016-08-01 |
| 10705032017299 | VISTA BRITE TIP | 588831E | 588831E | 2016-08-01 |
| 10705032017343 | VISTA BRITE TIP | 588834E | 588834E | 2016-08-01 |
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| 00884450840610 | Prelude Roadster™ | Merit Medical Systems, Inc. | DYB | 2026-10-20 |
| 00821329003455 | GORE GUIDRA Steerable Sheath | Greatbatch Ltd | DYB | 2026-10-14 |
| 00821329003462 | GORE GUIDRA Steerable Sheath | Greatbatch Ltd | DYB | 2026-10-14 |
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658879 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658893 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658909 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658916 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658923 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658930 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658947 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658954 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658961 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658978 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658985 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658992 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659005 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659012 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659029 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659036 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659043 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659050 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659067 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00850291007475 | Triever LA Transseptal Sheath | Inari Medical, Inc. | DYB | 2024-04-15 |
| 00810123710430 | ClotTriever Sheath | Inari Medical, Inc. | DYB | 2023-12-15 |
| 00733132629985 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2023-05-25 |
| 00733132628285 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2020-07-11 |
| 00733132628308 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2020-07-11 |