LiteTouch Schroeder Tenaculum

GUDID GYNXT22220

GYNEX CORPORATION

Uterine fibroid hook
Primary Device IDGYNXT22220
NIH Device Record Key96022b7f-e862-4016-80aa-bbbefb66b504
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiteTouch Schroeder Tenaculum
Version Model NumberT2222
Company DUNS012997685
Company NameGYNEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
HIBCCGYNXT22220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDCTenaculum, Uterine

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[GYNXT22220]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

Devices Manufactured by GYNEX CORPORATION

GYNX16000 - Gynex2024-01-03
GYNX291000 - Gynex2024-01-03
GYNX292000 - Gynex2024-01-03
GYNX293500 - Gynex2024-01-03
GYNX295500 - Gynex2024-01-03
GYNX297000 - Gynex2024-01-03
GYNX298000 - Gynex2024-01-03
GYNX298500 - Gynex2024-01-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.