FDA.reportPublic FDA data

Follicle Aspiration needle - single lumen flush

Primary DI
25425017503228
Brand
Follicle Aspiration needle - single lumen flush
Company
Gynetics Medical Products NV
Model
#4551 FAS FD
Device description
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Published
2016-11-03
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013497000FAS SET #4551Gynetics Medical Products NV2001-11-09MQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15425017503221PackageGS125In Commercial Distribution
25425017503228PackageGS150In Commercial Distribution
05425017503224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1542501750322115425017503221
2542501750322825425017503228
05425017503224054250175032245425017503224

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
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+3211645872info@gynetics.com

Regulatory Flags#

DUNS number
283088573
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425017501022Embryo transfer catheter #4219 Emtrac Delphin2016-10-14
05425017502005Intrauterine insemination cannula #4220 IUI2016-11-03
05425017502012Intrauterine insemination cannula #4220 IUI Memo2016-11-03
05425017502029Intrauterine insemination cannula #4225 Smooze2017-01-17
05425017502036Intrauterine insemination cannula #4225 Smooze Medium2017-01-17
05425017502043Intrauterine insemination cannula #4225 Smooze Long2017-01-17
05425017502050Intrauterine insemination cannula #4502 A Seminor Rigid2017-01-17
05425017502067Intrauterine insemination cannula #4502 B Seminor Flexible2017-01-17
05425017502081Intrauterine insemination cannula #4220 Plus2017-01-17
25425017502009Intrauterine insemination cannula #4220 IUI2016-11-03
25425017502016Intrauterine insemination cannula #4220 IUI Memo2016-11-03
25425017502023Intrauterine insemination cannula #4225 Smooze2017-01-17
25425017502030Intrauterine insemination cannula #4225 Smooze Medium2017-01-17
25425017502047Intrauterine insemination cannula #4225 Smooze Long2017-01-17
25425017502054Intrauterine insemination cannula #4502 A Seminor Rigid2017-01-17
25425017502061Intrauterine insemination cannula #4502 B Seminor Flexible2017-01-17
15425017502088Intrauterine insemination cannula #4220 Plus2017-01-17
05425017501312Embryo transfer catheter #4000 The Tulip2016-10-14
25425017501316Embryo transfer catheter #4000 The Tulip2016-10-14
05425017501114Soft embryo transfer catheter #2000 Semtrac W-2402016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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