Lletz Kogan Endocervical Speculum 038057

GUDID M803038057

Lletz Kogan Endocervical Speculum 2-4mm 11" (279mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable

• Primary Device ID: M803038057
• NIH Device Record Key: 21f0ef55-b0a3-4048-afc2-290932f2e70c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lletz Kogan Endocervical Speculum
• Version Model Number: Lletz Kogan Endocervical Speculum 2-4mm 11" (279m
• Catalog Number: 038057
• 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	M803038057 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

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

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

Moist Heat or Steam Sterilization

[M803038057]

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

On-Brand Devices [Lletz Kogan Endocervical Speculum ]

• M803038058: Lletz Kogan Endocervical Speculum 4-8mm 11" (279mm)
• M803038057: Lletz Kogan Endocervical Speculum 2-4mm 11" (279mm)