Gynex

Primary DI
GYNX31351
Brand
Gynex
Company
GYNEX CORPORATION
Model
3135
Published
2023-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHISystem, Abortion, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHISystem, Abortion, VacuumObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001555000SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26Sims Portex , Ltd.2000-08-02HHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX31351PrimaryHIBCC0
GYNX31350Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
012997685
Device count
24
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26
GYNX298000Gynex29-8002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
GYNX31301GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31300GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31350GynexGYNEX CORPORATIONHHI2023-12-26
04055207040027NARichard Wolf GmbHHHI2022-10-27
M803022721MedGyn Pipette MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022730MedGyn Pipette IV MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022734MedGyn Pipette IIMEDGYN PRODUCTS, INC.HHI2020-12-14
00821925030862Gyrus ACMIGyrus ACMI, LLCHHI2017-05-10
00821925000247003997-901 Gauze Sack and O-RingGyrus Acmi, Inc.HHI2017-05-10
00821925009561GYRUS ACMIGyrus ACMI, LLCHHI2017-05-09
00821925010475BERKELEYGyrus ACMI, LLCHHI2016-10-18
00821925008632Berkeley 1/2" Collection SetGyrus Acmi, Inc.HHI2016-10-13
00821925008625BERKELEY 1/2" (13mm) PRIMARYGyrus Acmi, Inc.HHI2016-10-13
00821925004184Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 fGyrus Acmi, Inc.HHI2016-10-11
00821925000919VACURETTE CURVED 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
0082192500094021163 Permeable Gauze Sacks (10/Pkg)Gyrus Acmi, Inc.HHI2016-10-11
00821925000964VACURETTE STRAIGHT 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000971VACURETTE STRAIGHT 10MM 10PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000988VACURETTE STRAIGHT 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000995VACURETTE STRAIGHT 12MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001015VACURETTE CURVED 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001022VACURETTE CURVED 10MMGyrus Acmi, Inc.HHI2016-10-11
00821925001039VACURETTE CURVED 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001046VACURETTE CURVED 12MM-10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004689VACURETTE STRAIGHT 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004702VACURETTE CURVED 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004719VACURETTE STRAIGHT 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004726VACURETTE "F" TIP 4MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004597VACURETTE "F" TIP 5MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004603VACURETTE "F" TIP 6MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11