FDA.reportPublic FDA data

Tefcat

Primary DI
10827002327211
Brand
Tefcat
Company
COOK INCORPORATED
Model
G32721
Catalog number
K-TFCT-301500
Device description
Tefcat Embryo Transfer Catheter
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQFCATHETER, ASSISTED REPRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQFCatheter, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002327211PackageGS110Not in Commercial Distribution
00827002327214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700232721110827002327211
00827002327214008270023272148270023272140827002327214

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction transfer catheter/setA device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580745043785ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043907ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044232ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044249ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043778ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745043891ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044263ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044287ET CatheterKITAZATO CORPORATIONMQF2024-09-09
M803TMI1297Clear Shapeable Intrauterine Insemination catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111400023FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111400030FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111400047FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400061T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111400085INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111400092STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111400108CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400122ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400139MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111400146CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400191ULTRASOFT FRYDMAN ® SET ECHOLABORATOIRE CCDMQF2023-12-05
03700111400214ULTRASOFT FRYDMAN ® SET MOCKLABORATOIRE CCDMQF2023-12-05
03700111400221ULTRASOFT FRYDMAN® SET MOCK ECHOLABORATOIRE CCDMQF2023-12-05
03700111400269FRYDMAN® ULTRASOFTLABORATOIRE CCDMQF2023-12-05
03700111400276FRYDMAN®ULTRASOFT ECHOLABORATOIRE CCDMQF2023-12-05
03700111400290CLASSIC ULTRASOFT 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400306CLASSIC ULTRASOFT MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400351ECHOGYN®EMBRYOVIEW M 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400368ECHOGYN® EMBRYOVIEW M MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400375ECHOGYN ® EMBRYOVIEW M 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400382ECHOGYN® EMBRYOVIEW M MOCK 18 CMLABORATOIRE CCDMQF2023-12-05