Lletz Weisman Speculum Left Side Open Medium Angled Closed Tube ANG038051

GUDID M803ANG038051

Open Medium Angled Closed Tube 1 3/8" x 4" (35mm x 102mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable
Primary Device IDM803ANG038051
NIH Device Record Key717b8d23-abf4-43d5-a8d7-7aa222908755
Commercial Distribution StatusIn Commercial Distribution
Brand NameLletz Weisman Speculum Left Side Open Medium Angled Closed Tube
Version Model NumberOpen Medium Angled Closed Tube 1 3/8" x 4" (35mm x
Catalog NumberANG038051
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
HIBCCM803ANG038051 [Primary]

FDA Product Code

HDFSpeculum, Vaginal, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


[M803ANG038051]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-28
Device Publish Date2025-04-19

Devices Manufactured by MEDGYN PRODUCTS, INC.

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M803038041 - Lletz Pederson Speculum Medium, Closed Tube2025-04-28 Lletz Pederson Speculum Medium, Closed Tube 7/8" x 4" (22mm x 102mm)
M803038042 - Lletz Pederson Speculum Large, Closed Tube2025-04-28 Lletz Pederson Speculum Large, Closed Tube 1" x 4 3/4" (25mm x 121mm)
M803038043 - Lletz Pederson Speculum Extra Large, Closed Tube2025-04-28 Lletz Pederson Speculum Extra Large, Closed Tube 1" x 6 1/2" (25mm x 165mm)

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