FDA.reportPublic FDA data

VYGON

Primary DI
30849884006927
Brand
VYGON
Company
Vygon Corporation
Model
AMS-547
Catalog number
AMS-547
Device description
FILTER AND NEEDLE KIT
Published
2025-05-23
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
PXOBone marrow biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXOBone Marrow Biopsy TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849884006923PackageGS11In Commercial Distribution
30849884006927PackageGS112In Commercial Distribution
00849884006926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084988400692310849884006923
3084988400692730849884006927
00849884006926008498840069268498840069260849884006926

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10198956419681CARDINAL HEALTHCardinal Health 200, LLCPXO2026-04-21
10198956418493CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-26
10198956413627CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-16
50198956413625CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-16
10198956388291CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-03
50198956388299CARDINAL HEALTHCardinal Health 200, LLCPXO2026-03-03
10198956357877CARDINAL HEALTHCardinal Health 200, LLCPXO2026-02-09
50198956357875CARDINAL HEALTHCardinal Health 200, LLCPXO2026-02-09
10198956220911CARDINAL HEALTHCardinal Health 200, LLCPXO2025-11-11
50198956220919CARDINAL HEALTHCardinal Health 200, LLCPXO2025-11-11
10198956194243CARDINAL HEALTHCardinal Health 200, LLCPXO2025-10-31
10198956163348CARDINAL HEALTHCardinal Health 200, LLCPXO2025-09-03
50198956163346CARDINAL HEALTHCardinal Health 200, LLCPXO2025-09-03
10198956094147CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-15
50198956094145CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-15
10198956131965CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-10
50198956131963CARDINAL HEALTHCardinal Health 200, LLCPXO2025-07-10
00849884006926VYGONVygon CorporationPXO2025-05-23
10198956056503CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-25
50198956056501CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-25
10197106956182CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-22
50197106956180CARDINAL HEALTHCardinal Health 200, LLCPXO2025-04-22
10197106953655CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-28
50197106953653CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-28
10197106927786CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-07
50197106927784CARDINAL HEALTHCardinal Health 200, LLCPXO2025-02-07
10197106878620CARDINAL HEALTHCardinal Health 200, LLCPXO2025-01-02
50197106878628CARDINAL HEALTHCardinal Health 200, LLCPXO2025-01-02
10197106801895CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09
50197106801893CARDINAL HEALTHCardinal Health 200, LLCPXO2024-12-09