FDA.reportPublic FDA data

VYGON

Primary DI
30849884001816
Brand
VYGON
Company
Vygon Corporation
Model
AMS-8307-1
Catalog number
AMS-8307-1
Device description
SUTURE TRAY
Published
2020-12-09
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 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
30849884001816PackageGS120In Commercial Distribution
00849884001815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400181630849884001816
00849884001815008498840018158498840018150849884001815

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120818216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 table
Primary DIBrandModelCatalogPublished
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
00849884007404VYGONPIP200100PIP2001002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956258662CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956381131CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956299528CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-09
10198956308206CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-06
10198956254732CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
10198956369351CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956410817CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956377479CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
10198956318380CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
10198956325135CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
10198956252134CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956299979CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956285712CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
10198956249868CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956192966CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
10198956199620CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956279797CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956233522CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
10198956219205CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956223288CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956187450CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-03
10198956185128CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
10198956192881CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
10198956132313CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04