FDA.reportPublic FDA data

Leaflet Tester

Primary DI
00896208000269
Brand
Leaflet Tester
Company
Corcym Canada Corp
Model
VT-100
Published
2021-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXNPROBE, TEST, HEART-VALVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXNProbe, Test, Heart-ValveCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896208000269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896208000269008962080002698962080002690896208000269

GMDN Terms#

Term, Definition table
TermDefinition
Heart valve prosthesis tester, single-useA sterile, pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
204322622
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896208000795PERCEVAL PLUSPVF-S2021-01-26
00896208000801PERCEVAL PLUSPVF-M2021-01-26
00896208000818PERCEVAL PLUSPVF-L2021-01-26
00896208000825PERCEVAL PLUSPVF-XL2021-01-26
00896208000528CROWN PRTCNA232016-08-08
00896208000535CROWN PRTCNA252016-08-08
00896208000542CROWN PRTCNA272016-08-08
00896208000412PERCEVALPVS21PVS212016-02-25
00896208000429PERCEVALPVS23PVS232016-02-25
00896208000436PERCEVALPVS25PVS252016-02-25
00896208000443PERCEVALPVS27PVS272016-02-25
08022057014924MITROFLOW VALSALVA CONDUITMVC262014-09-22
08022057014931MITROFLOW VALSALVA CONDUITMVC282014-09-22
00896208000108MITROFLOWLXA212014-09-19
00896208000115MITROFLOWLXA232014-09-19
00896208000122MITROFLOWLXA252014-09-19
00896208000139MITROFLOWLXA272014-09-19
00896208000153MITROFLOWDLA192014-09-19
00896208000160MITROFLOWDLA212014-09-19
00896208000177MITROFLOWDLA232014-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7408606028Duo Ti Expandable Interbody Fusion SystemSPINEOLOGY INC.LXN2023-12-29
M7405210002Universal Dilator SPINEOLOGY INC.LXN2023-12-19
M7405230003Universal Dilator SPINEOLOGY INC.LXN2023-12-19
00851788001167On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.LXN2023-08-09
05415067042316NAST. JUDE MEDICAL, INC.LXN2023-05-19
15415067042313NAST. JUDE MEDICAL, INC.LXN2023-05-19
M944AL105710Wexler Surgical, Inc.WEXLER SURGICAL, INC.LXN2020-07-31
00886333222940Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21
20886333222944Bone Access NeedleARGON MEDICAL DEVICES, INC.LXN2016-09-21