Schroeder Tenaculum, Angled

GUDID GYNX35300

GYNEX CORPORATION

Uterine fibroid hook
Primary Device IDGYNX35300
NIH Device Record Keyb9c4a32f-ea6a-4b3d-bc83-64a598010d41
Commercial Distribution StatusIn Commercial Distribution
Brand NameSchroeder Tenaculum, Angled
Version Model Number3530
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
HIBCCGYNX35300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDCTenaculum, Uterine

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[GYNX35300]

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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