FDA.reportPublic FDA data

VYGON

Primary DI
08498840009673
Brand
VYGON
Company
Vygon Corporation
Model
AMS-7306CP
Catalog number
AMS-7306CP
Device description
ULTRASOUND INSERTION KIT
Published
2016-09-15
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
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840009674PackageGS120In Commercial Distribution
08498840009673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000967438498840009674
08498840009673084988400096738498840009673

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.

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
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
08498840005071VYGONAMS-9294AMS-92942016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541739HALYARDMEDICAL ACTION INDUSTRIES INC.KDD2026-10-26
00850074437208OftalOnePackOFTAL-ONE INC.KDD2026-10-21
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
B562PKGS000100Micro Surgery KitWishbone Medical, Inc.KDD2024-12-30
B562PKGS000200Minor Surgery KitWishbone Medical, Inc.KDD2024-12-30
08800071700166Tiger GuardKims Med Co.,Ltd.KDD2024-10-21
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
08800071700050EZ Fan Funnel 2KimsMed Co.,Ltd.KDD2023-02-06
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15