FDA.reportPublic FDA data

VYGON

Primary DI
08498840000175
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
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010913000VYGON SPLIT CANNULA INTRODUCERVygon Corp.2001-09-28DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840000176PackageGS120In Commercial Distribution
58498840000170PackageGS110In Commercial Distribution
08498840000175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000017638498840000176
5849884000017058498840000170
08498840000175084988400001758498840000175

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA 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.

Regulatory Flags#

DUNS number
120818216
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849884007589VYGONVYML4S3001NVYML4S3001N2026-06-25
00849884007435VYGON2015SPI2015SPI2026-05-22
00849884007442VYGON2015SPIMST2015SPIMST2026-05-22
00849884007459VYGON3015SPI3015SPI2026-05-22
00849884007466VYGON3015SPIMST3015SPIMST2026-05-22
00849884007510VYGONVYML4S3001A-1VYML4S3001A-12026-05-22
00849884007527VYGONVYML5D3003AVYML5D3003A2026-05-22
00849884007541VYGONVIS-1045VIS-10452026-05-22
00849884007558VYGONVIS-1055VIS-10552026-05-22
00849884007350VYGON3017PI3017PI2026-05-01
00849884007374VYGON4018PI4018PI2026-05-01
00849884007398VYGONPIP200000PIP2000002026-05-01
00849884007497VYGONAMS-599AMS-5992026-04-24
00849884007480VYGONVY-MAXPROVY-MAXPRO2026-04-09
00849884007336VYGON2016PI2016PI2026-03-31
00849884007343VYGON2016SPI2016SPI2026-03-31
00849884007367VYGON3017SPI3017SPI2026-03-31
00849884007381VYGON4018SPI4018SPI2026-03-31
00849884007473VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00685447005285TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005292TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005308TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005315TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005322TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005339TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005346TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005353TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005360TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005377TorFlex Transseptal Guiding SheathBaylis Médicale Cie IncDYB2021-11-01
00685447005384TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005391TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005407TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005414TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005421TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005438TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005445TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005452TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005469TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
00685447005476TorFlex Transseptal Guiding SheathBOSTON SCIENTIFIC CORPORATIONDYB2021-11-01
10801902190519ARROWTELEFLEX INCORPORATEDDYB2021-09-02
00685447005605SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005612SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005629SupraCross Steerable SheathBaylis Médicale Cie IncDYB2021-04-19
00685447005643SureFlex Steerable Guiding SheathBaylis Médicale Cie IncDYB2021-04-19
00389701012353R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10
00389701012360R2P Destination SlenderTERUMO MEDICAL CORPORATIONDYB2020-04-10