FDA.reportPublic FDA data

Cook

Primary DI
00827002554764
Brand
Cook
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G55476
Catalog number
K-UCI-1735-R-CTU
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
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
00827002554764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002554764008270025547648270025547640827002554764

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
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