VYGON
- Primary DI
- 30849884004275
- Brand
- VYGON
- Company
- Vygon Corporation
- Model
- VYAA21G2
- Catalog number
- VYAA21G2
- Device description
- 21GA. X 2.5CM INTRODUCER NEEDLE
- Published
- 2020-03-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- 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 |
|---|---|
| K082580 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 30849884004275 | Package | GS1 | 10 | In Commercial Distribution |
| 00849884004274 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 30849884004275 | 30849884004275 | ||
| 00849884004274 | 00849884004274 | 849884004274 | 0849884004274 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 120818216
- 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 |
|---|---|---|---|---|
| 00849884007725 | VYGON | AMS-7203CP | AMS-7203CP | 2026-10-29 |
| 00849884007619 | VYGON | AMS-9869CS | AMS-9869CS | 2026-08-31 |
| 00849884007718 | VYGON | MS022 | MS022 | 2026-10-19 |
| 00849884007770 | VYGON | PIP100000T | PIP100000T | 2026-10-09 |
| 08498840001691 | VYGON | AMS-6180CP | AMS-6180CP | 2016-08-09 |
| 08498840001707 | VYGON | AMS-6186CP | AMS-6186CP | 2016-08-09 |
| 08498840002148 | VYGON | AMS-7192CS-2 | AMS-7192CS-2 | 2016-09-15 |
| 08498840002735 | VYGON | AMS-8133 | AMS-8133 | 2016-09-07 |
| 08498840002889 | VYGON | AMS-8180-3CP | AMS-8180-3CP | 2016-09-07 |
| 08498840002902 | VYGON | AMS-8181CP | AMS-8181CP | 2016-09-07 |
| 08498840002940 | VYGON | AMS-8198-1 | AMS-8198-1 | 2016-09-15 |
| 08498840002957 | VYGON | AMS-8198CS | AMS-8198CS | 2016-09-15 |
| 08498840002964 | VYGON | AMS-8199 | AMS-8199 | 2016-09-15 |
| 08498840003213 | VYGON | AMS-8280CP-4 | AMS-8280CP-4 | 2016-09-15 |
| 08498840003688 | VYGON | AMS-8423CP | AMS-8423CP | 2016-09-07 |
| 08498840004005 | VYGON | AMS-8485CP-1 | AMS-8485CP-1 | 2016-09-15 |
| 08498840004333 | VYGON | AMS-8712CP-1 | AMS-8712CP-1 | 2016-09-02 |
| 08498840004784 | VYGON | AMS-9093CP | AMS-9093CP | 2016-09-02 |
| 08498840004814 | VYGON | AMS-9152CP | AMS-9152CP | 2016-09-02 |
| 08498840004951 | VYGON | AMS-923CP | AMS-923CP | 2016-09-02 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00884450838129 | Prelude Roadster™ | Merit Medical Systems, Inc. | DYB | 2026-10-29 |
| 00198715836998 | EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING | FREUDENBERG MEDICAL, LLC | DYB | 2026-01-29 |
| 00389701011912 | GLIDESHEATH SLENDER TIBIAL PEDAL KIT | TERUMO MEDICAL CORPORATION | DYB | 2018-08-31 |
| 00389701011950 | GLIDESHEATH SLENDER | TERUMO MEDICAL CORPORATION | DYB | 2018-05-23 |
| 00389701011967 | GLIDESHEATH SLENDER | TERUMO MEDICAL CORPORATION | DYB | 2018-05-23 |
| 00389701011974 | GLIDESHEATH SLENDER | TERUMO MEDICAL CORPORATION | DYB | 2018-05-23 |
| 00389701009261 | PINNACLE | TERUMO MEDICAL CORPORATION | DYB | 2018-03-21 |
| 00382903840120 | BD Introsyte Autoguard | BECTON, DICKINSON AND COMPANY | DYB | 2016-10-20 |
| 00382903840083 | BD Introsyte-N Autoguard, BD Instaflash | BECTON, DICKINSON AND COMPANY | DYB | 2016-10-20 |
| 00382903840106 | BD Introsyte Autoguard | BECTON, DICKINSON AND COMPANY | DYB | 2016-10-20 |
| 00382903840113 | BD Introsyte Autoguard | BECTON, DICKINSON AND COMPANY | DYB | 2016-10-20 |
| 00389701006161 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006178 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006185 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006192 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006208 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006215 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006222 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006239 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006246 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006253 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006260 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006277 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006796 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006802 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006970 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006987 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701006994 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701007007 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |
| 00389701007168 | DESTINATION | TERUMO MEDICAL CORPORATION | DYB | 2016-09-24 |