Lletz Weisman Speculum Right Side Open Large Angled Closed Tube ANG038052

GUDID M803ANG038052

Open Large Angled Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable
Primary Device IDM803ANG038052
NIH Device Record Key042d3d6c-a4aa-430e-9b45-9f40d938365a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLletz Weisman Speculum Right Side Open Large Angled Closed Tube
Version Model NumberOpen Large Angled Closed Tube 1 3/8" x 4 3/4" (35m
Catalog NumberANG038052
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
HIBCCM803ANG038052 [Primary]

FDA Product Code

HDFSpeculum, Vaginal, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

Moist Heat or Steam Sterilization


[M803ANG038052]

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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M803038032 - Lletz Graves Speculum Large, Closed Tube 2025-04-28 Lletz Graves Speculum Large, Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm)
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M803038040 - Lletz Pederson Speculum Small, Closed Tube2025-04-28 Lletz Pederson Speculum Small, Closed Tube 1/2" x 3" (13mm x 76mm)
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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