VYGON

Primary DI
00849884004274
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
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
K082580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082580000SPECTRA GUIDEWIRE INTRODUCER NEEDLESpectra Medical Devices, Inc.2008-12-08DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884004275PackageGS110In Commercial Distribution
00849884004274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400427530849884004275
00849884004274008498840042748498840042740849884004274

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
00849884007725VYGONAMS-7203CPAMS-7203CP2026-10-29
00849884007619VYGONAMS-9869CSAMS-9869CS2026-08-31
00849884007718VYGONMS022MS0222026-10-19
00849884007770VYGONPIP100000TPIP100000T2026-10-09
08498840001691VYGONAMS-6180CPAMS-6180CP2016-08-09
08498840001707VYGONAMS-6186CPAMS-6186CP2016-08-09
08498840002148VYGONAMS-7192CS-2AMS-7192CS-22016-09-15
08498840002735VYGONAMS-8133AMS-81332016-09-07
08498840002889VYGONAMS-8180-3CPAMS-8180-3CP2016-09-07
08498840002902VYGONAMS-8181CPAMS-8181CP2016-09-07
08498840002940VYGONAMS-8198-1AMS-8198-12016-09-15
08498840002957VYGONAMS-8198CSAMS-8198CS2016-09-15
08498840002964VYGONAMS-8199AMS-81992016-09-15
08498840003213VYGONAMS-8280CP-4AMS-8280CP-42016-09-15
08498840003688VYGONAMS-8423CPAMS-8423CP2016-09-07
08498840004005VYGONAMS-8485CP-1AMS-8485CP-12016-09-15
08498840004333VYGONAMS-8712CP-1AMS-8712CP-12016-09-02
08498840004784VYGONAMS-9093CPAMS-9093CP2016-09-02
08498840004814VYGONAMS-9152CPAMS-9152CP2016-09-02
08498840004951VYGONAMS-923CPAMS-923CP2016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701011912GLIDESHEATH SLENDER TIBIAL PEDAL KITTERUMO MEDICAL CORPORATIONDYB2018-08-31
00389701011950GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011967GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006987DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006994DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007007DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701007168DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24