Suresample, Endometrial Sampler

GUDID GYNX31051

GYNEX CORPORATION

Endometrial biopsy kit
Primary Device IDGYNX31051
NIH Device Record Key0f0a5b69-1bd0-41db-9350-213d7e5d3028
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuresample, Endometrial Sampler
Version Model Number3105
Company DUNS012997685
Company NameGYNEX CORPORATION
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCGYNX31050 [Unit of Use]
HIBCCGYNX31051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCurette, Suction, Endometrial (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-10

On-Brand Devices [Suresample, Endometrial Sampler]

GYNX312143121
GYNX312033120
GYNX311513115
GYNX310513105

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