RESOLON

GUDID E203US881437

Resorba Medical GmbH

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: E203US881437
• NIH Device Record Key: d4c5b523-855f-45fa-91db-feb026cea30f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESOLON
• Version Model Number: RESOLON
• 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	E203US881437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143582

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

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 [RESOLON]

• E203US88172: RESOLON
• E203US88171: RESOLON
• E203US881525: RESOLON
• E203US88145: RESOLON
• E203US881440: RESOLON
• E203US881437: RESOLON
• E203US881427: RESOLON
• E203US881415: RESOLON
• E203OD137009: RESOLON
• E203OD136109: RESOLON
• E203OD133009: RESOLON
• E203OD132169: RESOLON
• E203OD132159: RESOLON
• E203OD132149: RESOLON
• E203OD132139: RESOLON
• E203OD132129: RESOLON
• E203OD132119: RESOLON
• E203OD132109: RESOLON
• E203OD132079: RESOLON
• E203OD132069: RESOLON
• E203OD132059: RESOLON
• E203OD132049: RESOLON
• E203OD132039: RESOLON
• E203OD132029: RESOLON
• E203OD132019: RESOLON
• E203OD132009: RESOLON
• E203OD131109: RESOLON