RESOLON TWIST

GUDID E203OD122109

Resorba Medical GmbH

Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: E203OD122109
• NIH Device Record Key: 8849d013-17f6-43e6-83eb-fdc58140a34a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESOLON TWIST
• Version Model Number: RESOLON TWIST
• 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	E203OD122109 [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: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [RESOLON TWIST]

• E203US61118: RESOLON TWIST
• E203US61117: RESOLON TWIST
• E203US61115: RESOLON TWIST
• E203OD127019: RESOLON TWIST
• E203OD127009: RESOLON TWIST
• E203OD122109: RESOLON TWIST
• E203OD122019: RESOLON TWIST
• E203OD122009: RESOLON TWIST
• E203OD121009: RESOLON TWIST