Lletz Collins Speculum Small Closed Tube 038047

GUDID M803038047

Lletz Collins Speculum Small Closed Tube 1 1/4" x 3 3/4" (32mm x 95mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable
Primary Device IDM803038047
NIH Device Record Key6ebc1f82-6533-46d2-8d77-07eb1c86f31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLletz Collins Speculum Small Closed Tube
Version Model NumberLletz Collins Speculum Small Closed Tube 1 1/4" x
Catalog Number038047
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
HIBCCM803038047 [Primary]

FDA Product Code

HDFSpeculum, Vaginal, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

Moist Heat or Steam Sterilization


[M803038047]

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.

M803038030 - Lletz Graves Speculum Small, Closed Tube 2025-04-28 Lletz Graves Speculum Small, Closed Tube 3/4 inch x 3inch (19mm x 76mm)
M803038031 - Lletz Graves Speculum Medium, Closed Tube 2025-04-28 Lletz Graves Speculum Medium, Closed Tube 1 3/8" x 4" (35mm x 102mm)
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)
M803038033 - Lletz Graves Speculum Extra Large, Closed Tube 2025-04-28 Lletz Graves Speculum Extra Large, Closed Tube 1 1/2" x 61/2" (38mm x 165mm)
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)

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