FDA.reportPublic FDA data

Cook

Primary DI
00827002443594
Brand
Cook
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G44359
Catalog number
K-OPS-8035-RWH-B-ET-US
Device description
Ovum Aspiration Needle, Single Lumen
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
MQENEEDLE, ASSISTED REPRODUCTION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983593000OVUM PICK-UP ASPIRATION NEEDLESCook Ob/Gyn1999-01-21MQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002443594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002443594008270024435948270024435940827002443594

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
00827002341746CookG34174K-DOPU-1728-T-A-602016-09-24
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

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