NYLON

GUDID E203US51540

Resorba Medical GmbH

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: E203US51540
• NIH Device Record Key: 99508283-a429-42bd-8bf4-bc059f4f215c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NYLON
• Version Model Number: NYLON
• 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	E203US51540 [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: 2019-01-30

On-Brand Devices [NYLON]

• E203US5157: NYLON
• E203US5156: NYLON
• E203US51540: NYLON
• E203US51523: NYLON
• E203US51520: NYLON
• E203US51519: NYLON
• E203US51518: NYLON
• E203US51517: NYLON
• E203US51516: NYLON
• E203US51515: NYLON
• E203US51514: NYLON
• E203US51513: NYLON
• E203US5148: NYLON
• E203US5147: NYLON
• E203US5146: NYLON
• E203US5145: NYLON
• E203US5144: NYLON
• E203US51439: NYLON
• E203US5143: NYLON
• E203US51419: NYLON
• E203US51416: NYLON
• E203US51415: NYLON
• E203US5116: NYLON
• E203US5149: NYLON
• E203US5061: NYLON
• E203US51539: NYLON
• E203US51442: -