FDA.reportPublic FDA data

Towako

Primary DI
00827002187429
Brand
Towako
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G18742
Catalog number
K-TTET-19-32.5-TOWAKO
Device description
Transmyometrial, Embryo Transfer Set
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
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
K983595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983595000TRANSMYOMETRIAL EMBRYO TRANSFER SETCook Ob/Gyn1999-02-08MQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002187429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002187429008270021874298270021874290827002187429

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
758568000
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002341753CookG34175K-DOPU-1735-T-A-602016-09-24
00827002341869CookG34186K-DOPU-1735-T-A-902016-09-24
00827002384279CookG38427K-OSN-1630-B-60-US2016-09-24
00827002384286CookG38428K-OSN-1630-B-90-US2016-09-24
00827002384309CookG38430K-OSN-1635-B-90-US2016-09-24
00827002384323CookG38432K-OSN-1725-B-60-US2016-09-24
00827002384330CookG38433K-OSN-1730-B-60-US2016-09-24
00827002388451CookG38845K-OPS-7035-RWH-ET-US2016-09-24
00827002443556CookG44355K-OPAA-1735-US2016-09-24
00827002443600CookG44360K-OPS-2130-US2016-09-24
00827002552487CookG55248K-OPS-1635-H-B-902016-09-24
00827002552517CookG55251K-OPS-1728-T-A-602016-09-24
00827002552524CookG55252K-OPS-1735-T-A-902016-09-24
00827002554788CookG55478K-OSN-1635-R-B-902016-09-24
00827002554801CookG55480K-OSN-1633-R-B-902016-09-24
00827002554832CookG55483K-OPS-1630-H-B-602016-09-24
00827002554870CookG55487K-OPS-1635-T-A-902016-09-24
00827002554900CookG55490K-OPS-1735-T-A-602016-09-24
00827002554917CookG55491K-OPS-1733-T-A-602016-09-24
00827002554931CookG55493K-OPS-1730-R-B-602016-09-24

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