Lateral Vaginal Wall Retractor Open 030966

GUDID M803030966

Wall Retractor Open 1/2" (13mm), 10" (254mm), Blade 1" x 2 1/2" (25mm x 64mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable
Primary Device IDM803030966
NIH Device Record Key6eaf3ac6-8fb7-4c71-94db-2a7f3fd2b688
Commercial Distribution StatusIn Commercial Distribution
Brand NameLateral Vaginal Wall Retractor Open
Version Model NumberWall Retractor Open 1/2" (13mm), 10" (254mm), Blad
Catalog Number030966
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM803030966 [Primary]

FDA Product Code

HDFSpeculum, Vaginal, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


[M803030966]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-03
Device Publish Date2025-05-26

On-Brand Devices [Lateral Vaginal Wall Retractor Open ]

M803030967Wall Retractor Open 1" (25mm), 10" (254mm), Blade 1" x 2 1/2" (25mm x 64mm)
M803030966Wall Retractor Open 1/2" (13mm), 10" (254mm), Blade 1" x 2 1/2" (25mm x 64mm)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.