FDA.reportPublic FDA data

Sydney IVF

Primary DI
00827002463011
Brand
Sydney IVF
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G46301
Catalog number
K-SICM-50-AA
Device description
SYDNEY IVF, CLEAVAGE MEDIUM
Published
2016-12-14
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
MQLMEDIA, REPRODUCTIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153290000Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst MediumWilliam A. Cook Australia Pty. , Ltd.2016-01-27MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002463011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002463011008270024630118270024630110827002463011

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
00827002603400COOKG60340ZBIS-10-45-41-US2025-06-24
00827002603417COOKG60341ZBIS-10-45-58-US2025-06-24
00827002603424COOKG60342ZBIS-10-61-41-US2025-06-24
00827002603431COOKG60343ZBIS-10-61-58-US2025-06-24
00827002603448COOKG60344ZBIS-12-45-41-US2025-06-24
00827002603455COOKG60345ZBIS-12-61-41-US2025-06-24
00827002603462COOKG60346ZBIS-12-45-58-US2025-06-24
00827002603479COOKG60347ZBIS-12-61-58-US2025-06-24
10827002325026ZenithG32502ZFEN-P-1-24-76-R2014-09-24
10827002325033ZenithG32503ZFEN-P-1-26-76-R2014-09-24
10827002325071ZenithG32507ZFEN-P-1-24-91-R2014-09-24
10827002325125ZenithG32512ZFEN-P-1-24-106-R2014-09-24
10827002325132ZenithG32513ZFEN-P-1-26-106-R2014-09-24
10827002325170ZenithG32517ZFEN-P-1-24-121-R2014-09-24
10827002325187ZenithG32518ZFEN-P-1-26-121-R2014-09-24
10827002325309ZenithG32530ZFEN-P-2-24-94-R2014-09-24
10827002325316ZenithG32531ZFEN-P-2-26-94-R2014-09-24
10827002325323ZenithG32532ZFEN-P-2-28-94-R2014-09-24
10827002325330ZenithG32533ZFEN-P-2-30-94-R2014-09-24
10827002325347ZenithG32534ZFEN-P-2-32-94-R2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161790127CaseBio®CaseBioscience IncMQL2026-10-31
07540161790134CaseBio®CaseBioscience IncMQL2026-10-31
00888937028508LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028515LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028522LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028539LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028546LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028614LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028621LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028638LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028645LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028652LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028669LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028676LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028683LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028690LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028706LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028713LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028935LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028942LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029017LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029024LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029031LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029130LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029147LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029154LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029161LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029178LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029185LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03