Gynex

Primary DI
GYNX31300
Brand
Gynex
Company
GYNEX CORPORATION
Model
3130
Published
2023-12-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
GYNX31301PrimaryHIBCC0
GYNX31300Unit 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012997685
Device count
5
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
true
Sterilization required before use
false

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
GYNX31351Gynex31352023-12-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
GYNX31301GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31351GynexGYNEX 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