Womed Leaf

GUDID 03770016478045

WOMED

Surgical anti-adhesion material, nonimplantable

• Primary Device ID: 03770016478045
• NIH Device Record Key: b97b3787-603b-4690-96a8-4a6a44339fd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Womed Leaf
• Version Model Number: LEAF-M
• Company DUNS: 270778790
• Company Name: WOMED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770016478045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240015

FDA Product Code

• MCN: Barrier, Absorbable, Adhesion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-01
• Device Publish Date: 2025-12-24

On-Brand Devices [Womed Leaf]

• 03770016478052: LEAF-L
• 03770016478045: LEAF-M
• 03770016478038: LEAF-S