ELEMENT Vascular Access System
- Primary DI
- 00810169720073
- Brand
- ELEMENT Vascular Access System
- Company
- PENUMBRA, INC.
- Model
- ELMNT17F65-A
- Device description
- Element 17 F Vascular Access System 65cm
- Published
- 2024-12-16
- 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 |
|---|---|
| K242520 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810169720073 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810169720073 | 00810169720073 | 810169720073 | 0810169720073 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device. |
Regulatory Flags#
- DUNS number
- 191077671
- 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
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810169723586 | swiftMATCH Coil, Extra Soft | 400SWXSFT510-A | 400SWXSFT510 | 2026-10-01 |
| 00810169723593 | swiftMATCH Coil, Extra Soft | 400SWXSFT615-A | 400SWXSFT615 | 2026-10-01 |
| 00810169723609 | swiftMATCH Coil, Soft | 400SWSFT610-A | 400SWSFT610 | 2026-10-01 |
| 00810169723616 | swiftMATCH Coil, Soft | 400SWSFT615-A | 400SWSFT615 | 2026-10-01 |
| 00810169723623 | swiftMATCH Coil, Soft | 400SWSFT715-A | 400SWSFT715 | 2026-10-01 |
| 00810169723630 | swiftMATCH Coil, Soft | 400SWSFT820-A | 400SWSFT820 | 2026-10-01 |
| 00810169723647 | swiftMATCH Coil, Standard | 400SWSTD408-A | 400SWSTD408 | 2026-10-01 |
| 00810169723654 | swiftMATCH Coil, Standard | 400SWSTD510-A | 400SWSTD510 | 2026-10-01 |
| 00810169723661 | swiftMATCH Coil, Standard | 400SWSTD515-A | 400SWSTD515 | 2026-10-01 |
| 00810169723678 | swiftMATCH Coil, Standard | 400SWSTD615-A | 400SWSTD615 | 2026-10-01 |
| 00810169723685 | swiftMATCH Coil, Standard | 400SWSTD620-A | 400SWSTD620 | 2026-10-01 |
| 00810169723692 | swiftMATCH Coil, Standard | 400SWSTD725-A | 400SWSTD725 | 2026-10-01 |
| 00810169723708 | swiftMATCH Coil, Standard | 400SWSTD830-A | 400SWSTD830 | 2026-10-01 |
| 00810169724217 | Ruby XL Coil System | RBYPODXL0310-A | RBYPODXL0310 | 2026-10-01 |
| 00810169724224 | Ruby XL Coil System | RBYPODXL0320-A | RBYPODXL0320 | 2026-10-01 |
| 00810169724231 | Ruby XL Coil System | RBYPODXL0720-A | RBYPODXL0720 | 2026-10-01 |
| 00810169724248 | Ruby XL Coil System | RBYPODXL0755-A | RBYPODXL0755 | 2026-10-01 |
| 00810169724255 | Ruby XL Coil System | RBYPODXL0830-A | RBYPODXL0830 | 2026-10-01 |
| 00810169724262 | Ruby XL Coil System | RBYPODXL0930-A | RBYPODXL0930 | 2026-10-01 |
| 00810169724279 | Ruby XL Coil System | RBYPODXL0955-A | RBYPODXL0955-A | 2026-10-01 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 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 |