INT
- Primary DI
- 26950900921128
- Brand
- INT
- Company
- Shanghai Kindly Medical Instruments Co., Ltd.
- Model
- TR03A
- Published
- 2023-08-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|---|
| K180178 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K180178 | 000 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 26950900921128 | Package | GS1 | 5 | In Commercial Distribution |
| 46950900921122 | Package | GS1 | 200 | In Commercial Distribution |
| 06950900921124 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 26950900921128 | 26950900921128 | |
| 46950900921122 | 46950900921122 | |
| 06950900921124 | 06950900921124 | 6950900921124 |
GMDN Terms#
| Term | Definition |
|---|---|
| Interventional radiology percutaneous-access kit, single-use | A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 420827639
- 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
- true
- 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 |
|---|---|---|---|---|
| 06950900900693 | INT,SlideCath | ACJL605F1125 | 2023-09-11 | |
| 06950900900709 | INT,SlideCath | ACJL606F1125 | 2023-09-11 | |
| 06950900900716 | INT,SlideCath | ACJR304F1100 | 2023-09-11 | |
| 06950900900723 | INT,SlideCath | ACJR307F1100 | 2023-09-11 | |
| 06950900900730 | INT,SlideCath | ACJR355F1125 | 2023-09-11 | |
| 06950900900747 | INT,SlideCath | ACJR356F1125 | 2023-09-11 | |
| 06950900900754 | INT,SlideCath | ACJR405F1125 | 2023-09-11 | |
| 06950900900761 | INT,SlideCath | ACJR406F1125 | 2023-09-11 | |
| 06950900900778 | INT,SlideCath | ACJR455F1100 | 2023-09-11 | |
| 06950900900785 | INT,SlideCath | ACJR456F1100 | 2023-09-11 | |
| 06950900900792 | INT,SlideCath | ACJR456F1125 | 2023-09-11 | |
| 06950900900808 | INT,SlideCath | ACJR457F1100 | 2023-09-11 | |
| 06950900900815 | INT,SlideCath | ACJR505F1125 | 2023-09-11 | |
| 06950900900822 | INT,SlideCath | ACJR506F1125 | 2023-09-11 | |
| 06950900900839 | INT,SlideCath | ACJR605F1125 | 2023-09-11 | |
| 06950900900846 | INT,SlideCath | ACJR606F1125 | 2023-09-11 | |
| 06950900900853 | INT,SlideCath | ACTIG24F1100 | 2023-09-11 | |
| 06950900900860 | INT,SlideCath | ACTIG25F1100 | 2023-09-11 | |
| 06950900900877 | INT,SlideCath | ACTIG27F1100 | 2023-09-11 | |
| 06950900900884 | INT,SlideCath | ACTIG34F1100 | 2023-09-11 |
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 |