RESOPREN

GUDID E203US771416

Resorba Medical GmbH

Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture Polyvinylidene fluoride suture

• Primary Device ID: E203US771416
• NIH Device Record Key: 82b1e53d-9b9a-4d59-900d-70769c81b14a
• 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	E203US771416 [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