FDA.reportPublic FDA data

VYGON

Primary DI
08498840003527
Brand
VYGON
Company
Vygon Corporation
Model
AMS-8368
Catalog number
AMS-8368
Device description
SUTURE SET
Published
2016-09-07
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
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840003528PackageGS120In Commercial Distribution
08498840003527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000352838498840003528
08498840003527084988400035278498840003527

GMDN Terms#

Term, Definition table
TermDefinition
Suture kit, non-medicatedA collection of sterile instruments and dressings necessary to perform a suturing procedure; it does not contain any pharmaceuticals. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849884007824VYGONAMS-9837CP-8AMS-9837CP-82026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538333HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538340HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538357HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538371HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538395HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538401HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538418HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538432HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538456HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538470HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160538487HalyardAVID MEDICAL, INC.OVN2026-09-21
10809160538494HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-21
10809160536902HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536940HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536971HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536988HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160536995HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537060HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537145HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537152HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537169HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537176HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537183HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537190HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537206HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537213HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537220HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537237HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537244HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18
10809160537251HalyardMEDICAL ACTION INDUSTRIES INC.OVN2026-09-18