FDA.reportPublic FDA data

AY Cygnet Clamp

Primary DI
00850001784962
Brand
AY Cygnet Clamp
Company
VITALITEC INTERNATIONAL, INC.
Model
VSAY-LK86
Catalog number
VSAY-LK86
Device description
Reusable, Surgical Vascular Clamp for vessel occlusionLambert Kay
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010727000FLEXLINE CLAMPNovare Surgical Systems, Inc.2002-08-09DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001784962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001784962008500017849628500017849620850001784962

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length86Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
508.747.6033lylehoward@aol.com

Regulatory Flags#

DUNS number
121464288
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044817016CYGNET Sterilization Tray VTI1020520-012023-05-01
00857987006255Vitalitec Shovel RetractorsV90952018-12-11
00850001784580Vitalitec MI Ball Point ProbeMI-70862018-12-13
00850001784528Vitalitec Surgical ScissorsMI-30332018-12-13
00850001784566Vitalitec Surgical ScissorsMI-35332018-12-13
00850001784573Vitalitec Surgical ScissorsMI-35612018-12-13
00850001784948AY Cygnet Clampvsay00064vsay000642022-08-17
00852621004697MICA AppliersPLM535-1PLM535-12022-08-17
00850001784917Vitalitec Clip AppliersPBC228PBC2282022-08-16
00850001784924Vitalitec Clip AppliersPVC328PVC3282022-08-16
00850001784931Vitalitec Clip AppliersPOC428POC4282022-08-16
00850001784955AY Cygnet ClampVSAY-LK66VSAY-LK662022-08-16
00850001784979MICA AppliersPWM635-1PWM635-12022-08-16
00850001784986MICA AppliersPRM135-1PRM135-12022-08-16
00850001784993MICA AppliersPJM135-1PJM135-12022-08-16
00850044817009MICA AppliersPBM235-1PBM235-12022-08-16
00850001784689Vitalitec Clip AppliersPWT620PWT6202022-08-10
00850001784696Vitalitec Clip AppliersPJT120PJT1202022-08-10
00850001784702Vitalitec Clip AppliersPRT120PRT1202022-08-10
00850001784719Vitalitec Clip AppliersPLT520PLT5202022-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436636MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436643MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436681MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434335MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
00846159036411SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00846159036428SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776417154MillenniumAvalign Technologies, Inc.DXC2026-08-19
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30