FDA.reportPublic FDA data

Sydney IVF

Primary DI
00827002483446
Brand
Sydney IVF
Company
COOK INCORPORATED
Model
G48344
Catalog number
K-JET-7002-SIVF
Device description
Sydney IVF, Malleable Obturator
Published
2016-09-24
Public version status
Update
Distribution status
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
00827002483446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002483446008270024834468270024834460827002483446

GMDN Terms#

Term, Definition table
TermDefinition
Catheter styletA metal wire or flexible rod, typically with a plastic knob at the proximal end, that is inserted into the lumen of a catheter or cannula to provide internal reinforcement to increase the stiffness enough to facilitate manipulation and introduction into the body for various procedures. It is available in various lengths, diameters, and degrees of rigidity. Some types can include small passive magnets that generate a magnetic field which is detectable by an external catheter stylet magnet detector. 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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971855770902Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770919Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770926Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770933Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770940Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770957Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
14580745043782ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043904ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044239ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044246ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043775ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745043898ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044260ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044284ET CatheterKITAZATO CORPORATIONMQF2024-09-09
06971982050328VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050335VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050342VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051066VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051073VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
M803TMI1290Embryo Transfer Catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111425026FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111425033FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111425040FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425064T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111425088INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111425095STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111425101CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111425125ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425132MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111425149CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05