VYGON
- Primary DI
- 58498840000170
- Brand
- VYGON
- Company
- Vygon Corporation
- Model
- 1262.30N
- Catalog number
- 1262.30N
- Device description
- 20 GA. SPLITTING INTRODUCER NEEDLE
- Published
- 2016-08-18
- Public version status
- Update
- 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 |
|---|---|
| K010913 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 38498840000176 | Package | GS1 | 20 | In Commercial Distribution |
| 58498840000170 | Package | GS1 | 10 | In Commercial Distribution |
| 08498840000175 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 38498840000176 | 38498840000176 | |
| 58498840000170 | 58498840000170 | |
| 08498840000175 | 08498840000175 | 8498840000175 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular catheter introduction needle | A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device. |
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#
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|---|---|---|---|---|
| 00849884007718 | VYGON | MS022 | MS022 | 2026-10-19 |
| 00849884007770 | VYGON | PIP100000T | PIP100000T | 2026-10-09 |
| 00849884007824 | VYGON | AMS-9837CP-8 | AMS-9837CP-8 | 2026-09-25 |
| 00849884007589 | VYGON | VYML4S3001N | VYML4S3001N | 2026-06-25 |
| 00849884007435 | VYGON | 2015SPI | 2015SPI | 2026-05-22 |
| 00849884007442 | VYGON | 2015SPIMST | 2015SPIMST | 2026-05-22 |
| 00849884007459 | VYGON | 3015SPI | 3015SPI | 2026-05-22 |
| 00849884007466 | VYGON | 3015SPIMST | 3015SPIMST | 2026-05-22 |
| 00849884007510 | VYGON | VYML4S3001A-1 | VYML4S3001A-1 | 2026-05-22 |
| 00849884007527 | VYGON | VYML5D3003A | VYML5D3003A | 2026-05-22 |
| 00849884007541 | VYGON | VIS-1045 | VIS-1045 | 2026-05-22 |
| 00849884007558 | VYGON | VIS-1055 | VIS-1055 | 2026-05-22 |
| 00849884007350 | VYGON | 3017PI | 3017PI | 2026-05-01 |
| 00849884007374 | VYGON | 4018PI | 4018PI | 2026-05-01 |
| 00849884007398 | VYGON | PIP200000 | PIP200000 | 2026-05-01 |
| 00849884007497 | VYGON | AMS-599 | AMS-599 | 2026-04-24 |
| 00849884007480 | VYGON | VY-MAXPRO | VY-MAXPRO | 2026-04-09 |
| 00849884007336 | VYGON | 2016PI | 2016PI | 2026-03-31 |
| 00849884007343 | VYGON | 2016SPI | 2016SPI | 2026-03-31 |
| 00849884007367 | VYGON | 3017SPI | 3017SPI | 2026-03-31 |
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