Echosampler

Primary DI
25425017500036
Brand
Echosampler
Company
Gynetics Medical Products NV
Model
#5164 Echosampler
Device description
Endometrial curette
Published
2017-01-17
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
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
15425017500039PackageGS125In Commercial Distribution
25425017500036PackageGS1125In Commercial Distribution
05425017500032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1542501750003915425017500039
2542501750003625425017500036
05425017500032054250175000325425017500032

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
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
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
05425017500377GynosamplerGynetics Medical Products NVHFF2016-10-04
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