Lletz Klopfer Speculum 038054

GUDID M803038054

Lletz Klopfer Speculum 1 3/8”x3 1/2” (35mm x 89mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable

• Primary Device ID: M803038054
• NIH Device Record Key: 6a7fc5f5-04c3-45ce-8c3c-79aa5e325e56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lletz Klopfer Speculum
• Version Model Number: Lletz Klopfer Speculum 1 3/8”x3 1/2” (35mm x 89mm)
• Catalog Number: 038054
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M803038054 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

[M803038054]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-28
• Device Publish Date: 2025-04-19

Devices Manufactured by MEDGYN PRODUCTS, INC.

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• 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 Tube: 2025-04-28 Lletz Pederson Speculum Small, Closed Tube 1/2" x 3" (13mm x 76mm)
• M803038041 - Lletz Pederson Speculum Medium, Closed Tube: 2025-04-28 Lletz Pederson Speculum Medium, Closed Tube 7/8" x 4" (22mm x 102mm)
• M803038042 - Lletz Pederson Speculum Large, Closed Tube: 2025-04-28 Lletz Pederson Speculum Large, Closed Tube 1" x 4 3/4" (25mm x 121mm)
• M803038043 - Lletz Pederson Speculum Extra Large, Closed Tube: 2025-04-28 Lletz Pederson Speculum Extra Large, Closed Tube 1" x 6 1/2" (25mm x 165mm)