MOPYLEN

GUDID E203US71513

Resorba Medical GmbH

Polyolefin suture, monofilament

• Primary Device ID: E203US71513
• NIH Device Record Key: fd0b9d06-249c-4c1b-9b04-759fe2aeaf5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOPYLEN
• Version Model Number: MOPYLEN
• 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	E203US71513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143582

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 2019-01-30

On-Brand Devices [MOPYLEN]

• E203US7173: MOPYLEN
• E203US7157: MOPYLEN
• E203US7156: MOPYLEN
• E203US7155: MOPYLEN
• E203US71530: MOPYLEN
• E203US71526: MOPYLEN
• E203US71521: MOPYLEN
• E203US7152: MOPYLEN
• E203US71514: MOPYLEN
• E203US71513: MOPYLEN
• E203US71512: MOPYLEN
• E203US71511: MOPYLEN
• E203US71510: MOPYLEN
• E203US7149: MOPYLEN
• E203US7148: MOPYLEN
• E203US71418: MOPYLEN
• E203US71415: MOPYLEN
• E203US7076: MOPYLEN
• E203US70737: MOPYLEN
• E203US70718: MOPYLEN
• E203US70711: MOPYLEN
• E203US7038: MOPYLEN
• E203US7035: MOPYLEN
• E203US7034: MOPYLEN
• E203US7033: MOPYLEN
• E203US7032: MOPYLEN
• E203US7031: MOPYLEN
• E203US7026: MOPYLEN
• E203US7025: MOPYLEN
• E203US70244: MOPYLEN
• E203US70243: MOPYLEN
• E203US70241: MOPYLEN
• E203US70240: MOPYLEN
• E203US70238: MOPYLEN
• E203US70222: MOPYLEN
• E203US70221: MOPYLEN
• E203US70220: MOPYLEN
• E203US70219: MOPYLEN
• E203US70218: MOPYLEN
• E203US70217: MOPYLEN
• E203US70215: MOPYLEN
• E203US70212: MOPYLEN
• E203US70211: MOPYLEN
• E203US70210: MOPYLEN
• E203US7077: MOPYLEN
• E203US7094: MOPYLEN
• E203US70712: MOPYLEN
• E203US71550: MOPYLEN
• E203US71436: MOPYLEN