FDA.reportPublic FDA data

Embryo transfer catheter

Primary DI
05425017501312
Brand
Embryo transfer catheter
Company
Gynetics Medical Products NV
Model
#4000 The Tulip
Device description
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
Published
2016-10-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQFCatheter, Assisted Reproduction

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013536000EMTRAC; DELPHIN; SEMTRAC 2000 SETGynetics Medical Products NV2001-11-30MQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15425017501319PackageGS125In Commercial Distribution
25425017501316PackageGS175In Commercial Distribution
05425017501312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1542501750131915425017501319
2542501750131625425017501316
05425017501312054250175013125425017501312

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction catheter setA collection of sterile devices 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)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.21Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+3211645872info@gynetics.com

Regulatory Flags#

DUNS number
283088573
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425017501022Embryo transfer catheter #4219 Emtrac Delphin2016-10-14
05425017502005Intrauterine insemination cannula #4220 IUI2016-11-03
05425017502012Intrauterine insemination cannula #4220 IUI Memo2016-11-03
05425017502029Intrauterine insemination cannula #4225 Smooze2017-01-17
05425017502036Intrauterine insemination cannula #4225 Smooze Medium2017-01-17
05425017502043Intrauterine insemination cannula #4225 Smooze Long2017-01-17
05425017502050Intrauterine insemination cannula #4502 A Seminor Rigid2017-01-17
05425017502067Intrauterine insemination cannula #4502 B Seminor Flexible2017-01-17
05425017502081Intrauterine insemination cannula #4220 Plus2017-01-17
25425017502009Intrauterine insemination cannula #4220 IUI2016-11-03
25425017502016Intrauterine insemination cannula #4220 IUI Memo2016-11-03
25425017502023Intrauterine insemination cannula #4225 Smooze2017-01-17
25425017502030Intrauterine insemination cannula #4225 Smooze Medium2017-01-17
25425017502047Intrauterine insemination cannula #4225 Smooze Long2017-01-17
25425017502054Intrauterine insemination cannula #4502 A Seminor Rigid2017-01-17
25425017502061Intrauterine insemination cannula #4502 B Seminor Flexible2017-01-17
15425017502088Intrauterine insemination cannula #4220 Plus2017-01-17
25425017501316Embryo transfer catheter #4000 The Tulip2016-10-14
05425017501114Soft embryo transfer catheter #2000 Semtrac W-2402016-10-14
25425017501118Soft embryo transfer catheter #2000 Semtrac W-2402016-10-14

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