Rotating Burke Biopsy Punch 030107

GUDID M803030107

Rotating Burke Biopsy Punch

MEDGYN PRODUCTS, INC.

Intrauterine curette, manual

• Primary Device ID: M803030107
• NIH Device Record Key: dd1714da-ccca-44bb-b88d-e45c2405d63e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotating Burke Biopsy Punch
• Version Model Number: Rotating Burke Biopsy Punch
• Catalog Number: 030107
• 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	M803030107 [Primary]

FDA Product Code

• KOH: Instrument, Manual, General Obstetric-Gynecologic

Sterilization

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

[M803030107]

Moist Heat or Steam Sterilization

[M803030107]

Moist Heat or Steam Sterilization

[M803030107]

Moist Heat or Steam Sterilization

[M803030107]

Moist Heat or Steam Sterilization

[M803030107]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-24
• Device Publish Date: 2025-11-16

Devices Manufactured by MEDGYN PRODUCTS, INC.

• M8030030134 - Baby Tischler Biopsy Punch Titanium: 2025-11-24 Baby Tischler Biopsy Punch Titanium 10" (254mm) - Angled Up
• M8030030139 - Tischler Biopsy Punch Titanium: 2025-11-24 Tischler Biopsy Punch Titanium 8 1/2" (216mm) - Angled Left
• M803029801 - Tischler Biopsy Punch: 2025-11-24 Tischler Biopsy Punch 10" (254mm) Up
• M803029802 - Tischler Biopsy Punch: 2025-11-24 Tischler Biopsy Punch 10" (254mm) Down
• M803029803 - Tischler Biopsy Punch: 2025-11-24 Tischler Biopsy Punch 10" (254mm) Left
• M803029804 - Tischler Biopsy Punch: 2025-11-24 Tischler Biopsy Punch 10" (254mm) Right
• M803029811 - Baby Tischler Biopsy Punch: 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Up
• M803029812 - Baby Tischler Biopsy Punch: 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Down