MedGyn Flexible/Karman Cannula-Curette 4mm 022004K

GUDID M803K022004

4mm Flexible/Karman Curette

MEDGYN PRODUCTS, INC.

Intrauterine cannula, single-use
Primary Device IDM803K022004
NIH Device Record Keydd2819d3-64c6-4fa8-a022-11d185e4aaf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedGyn Flexible/Karman Cannula-Curette 4mm
Version Model Number4mm Flexible/Karman Curette
Catalog Number022004K
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCM803K022004 [Primary]

FDA Product Code

HCYCurette, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-25
Device Publish Date2025-04-17

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