MedGyn Disposable Amnio Hook 020301

GUDID M803020301

MedGyn Disposable Amnio Hook

MEDGYN PRODUCTS, INC.

Amniotome, single-use
Primary Device IDM803020301
NIH Device Record Key79e010ea-28e4-4eb6-8d80-def739caf821
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedGyn Disposable Amnio Hook
Version Model NumberAmniotome
Catalog Number020301
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM803020301 [Primary]

FDA Product Code

HGEAmniotome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

Devices Manufactured by MEDGYN PRODUCTS, INC.

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