FDA.reportPublic FDA data

Cook

Primary DI
00827002341746
Brand
Cook
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G34174
Catalog number
K-DOPU-1728-T-A-60
Device description
Ovum Aspiration Needle, Single Lumen
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
MQENEEDLE, ASSISTED REPRODUCTION

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002341746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002341746008270023417468270023417460827002341746

GMDN Terms#

Term, Definition table
TermDefinition
IVF oocyte aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
758568000
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
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
10827002325002ZenithG32500ZFEN-D-12-28-106-C2014-09-24
10827002325019ZenithG32501ZFEN-D-12-28-121-C2014-09-24
10827002325026ZenithG32502ZFEN-P-1-24-76-R2014-09-24
10827002325033ZenithG32503ZFEN-P-1-26-76-R2014-09-24
10827002325040ZenithG32504ZFEN-P-1-28-76-R2014-09-24
10827002325057ZenithG32505ZFEN-P-1-30-76-R2014-09-24
10827002325064ZenithG32506ZFEN-P-1-32-76-R2014-09-24
10827002325071ZenithG32507ZFEN-P-1-24-91-R2014-09-24
10827002325088ZenithG32508ZFEN-P-1-26-91-R2014-09-24
10827002325095ZenithG32509ZFEN-P-1-28-91-R2014-09-24
10827002325101ZenithG32510ZFEN-P-1-30-91-R2014-09-24
10827002325118ZenithG32511ZFEN-P-1-32-91-R2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841436122211Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122228Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122242Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122266Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122273Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122297Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122310Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122334Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122358Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436122365Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436123225Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
10841436123249Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.MQE2024-06-20
04580745043709OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
04580745043723OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
04580745043730OPU NeedleKITAZATO CORPORATIONMQE2024-05-16
03700111400801HOC CLASSIC WITH VALVE Aspiration tube 2 x 33 cmLABORATOIRE CCDMQE2023-12-05
03700111400818HOC CLASSIC WITHOUT VALVE Aspiration tube 67 cmLABORATOIRE CCDMQE2023-12-05
03700111400825HOC2 CLASSIC WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111400832OPS CLASSIC WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400849OPS CLASSIC WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400863HOC COLLECTION VIAL 30MLLABORATOIRE CCDMQE2023-12-05
03700111400917OPS A.R.T. OF C.C.D. ® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400924OPS A.R.T. OF C.C.D. ®WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400931HOC A.R.T. OF C.C.D.® WITHOUT VALVELABORATOIRE CCDMQE2023-12-05
03700111400948HOC A.R.T. OF C.C.D.® WITH VALVELABORATOIRE CCDMQE2023-12-05
03700111400955HOC2 A.R.T. OF C.C.D.® WITHOUT VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111400962HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUGLABORATOIRE CCDMQE2023-12-05
03700111400979OVO A.R.T. OF C.C.D.® NEEDLE 30CM G17LABORATOIRE CCDMQE2023-12-05
03700111400993OOCYTE RETRIEVAL NEEDLE30CM G17LABORATOIRE CCDMQE2023-12-05
03700111401006OOCYTE RETRIEVAL NEEDLE 25CM G17LABORATOIRE CCDMQE2023-12-05