FDA.reportPublic FDA data

Gynosampler

Primary DI
05425017500377
Brand
Gynosampler
Company
Gynetics Medical Products NV
Model
#9164
Device description
The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
Published
2016-10-04
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
HFFAspirator, Endometrial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFFAspirator, EndometrialObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903002000PROBET (TM)Gynopharma, Inc.1991-04-05HFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15425017500374PackageGS125In Commercial Distribution
75425017500376PackageGS1250In Commercial Distribution
05425017500377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1542501750037415425017500374
7542501750037675425017500376
05425017500377054250175003775425017500377

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy kitA collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length262Millimeter
Outer Diameter2.93Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
283088573
Device count
1
Lot or batch
true
Expiration date on label
true
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
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.HFF2021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.HFF2021-08-13
05425017500032EchosamplerGynetics Medical Products NVHFF2017-01-17
25425017500036EchosamplerGynetics Medical Products NVHFF2017-01-17
00827002461901GoldsteinCOOK INCORPORATEDHFF2016-09-24
10827002461908GoldsteinCOOK INCORPORATEDHFF2016-09-24
10805360016831GynosamplerVITROLIFE INC.HFF2016-09-23
00888937011258Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011265Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
00888937011241Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011259Wallach EndocellCoopersurgical, Inc.HFF2016-08-16
30888937011266Wallach EndocellCoopersurgical, Inc.HFF2016-08-16