RESOPREN

GUDID E203US77155

Resorba Medical GmbH

Polyvinylidene fluoride suture

• Primary Device ID: E203US77155
• NIH Device Record Key: e02a85ad-58aa-4cf5-8f21-155742b7940c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESOPREN
• Version Model Number: RESOPREN
• Company DUNS: 341053195
• Company Name: Resorba Medical GmbH
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E203US77155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143582

FDA Product Code

• MXW: Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-02-01

On-Brand Devices [RESOPREN]

• E203US77155: RESOPREN
• E203US77154: RESOPREN
• E203US771534: RESOPREN
• E203US77153: RESOPREN
• E203US771527: RESOPREN
• E203US771526: RESOPREN
• E203US771525: RESOPREN
• E203US771524: RESOPREN
• E203US771520: RESOPREN
• E203US77152: RESOPREN
• E203US771517: RESOPREN
• E203US77151: RESOPREN
• E203US771416: RESOPREN
• E203US771415: RESOPREN
• E203US771401: RESOPREN
• E203US770210: RESOPREN