POLYESTER

GUDID E203US8112

Resorba Medical GmbH

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: E203US8112
• NIH Device Record Key: f8ab90ca-0b37-447e-a6f4-76ea3415c7fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYESTER
• Version Model Number: POLYESTER
• 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	E203US8112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143582

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2019-01-31

On-Brand Devices [POLYESTER]

• E203US81428: POLYESTER
• E203US81423: POLYESTER
• E203US81422: POLYESTER
• E203US8112: POLYESTER
• E203US80217: POLYESTER
• E203US80216: POLYESTER