Teale Tenaculum, Slight Curve

GUDID GYNX35360

GYNEX CORPORATION

Uterine fibroid hook
Primary Device IDGYNX35360
NIH Device Record Keybdf68372-80af-4db9-98d4-edaa1c57b129
Commercial Distribution StatusIn Commercial Distribution
Brand NameTeale Tenaculum, Slight Curve
Version Model Number3536
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
HIBCCGYNX35360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDCTenaculum, Uterine

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[GYNX35360]

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

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