SILK

GUDID E203US41426

Resorba Medical GmbH

Silk suture, sterile

• Primary Device ID: E203US41426
• NIH Device Record Key: 55b29a9e-ff3b-4a28-962a-fd9f6db20670
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILK
• Version Model Number: SILK
• 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	E203US41426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143582

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

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: 2019-02-04

On-Brand Devices [SILK]

• E203USSG755: SILK
• E203USSG655: SILK
• E203USG820: SILK
• E203USG720: SILK
• E203USG6105: SILK
• E203USG6100: SILK
• E203USG5105: SILK
• E203USG5100: SILK
• E203USG4105: SILK
• E203USG3105: SILK
• E203USA40309: SILK
• E203USA40259: SILK
• E203USA40250: SILK
• E203US61431: SILK
• E203US4170: SILK
• E203US41533: SILK
• E203US41532: SILK
• E203US41524: SILK
• E203US41428: SILK
• E203US41426: SILK
• E203US41425: SILK
• E203US41423: SILK
• E203US41422: SILK
• E203US41418: SILK
• E203US41413: SILK
• E203US41412: SILK
• E203US40728: SILK
• E203US40727: SILK
• E203US40616: SILK
• E203US4028: SILK
• E203US4027: SILK
• E203US4026: SILK
• E203US40243: SILK
• E203US40228: SILK
• E203US40227: SILK
• E203US40226: SILK