SUPOLENE

GUDID E203US91426

Resorba Medical GmbH

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: E203US91426
• NIH Device Record Key: b7927df6-7563-4396-9541-af5b57a9fe33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPOLENE
• Version Model Number: SUPOLENE
• 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	E203US91426 [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: 2019-02-03

On-Brand Devices [SUPOLENE]

• E203USSW655: SUPOLENE
• E203USSW5105: SUPOLENE
• E203USM90613: SUPOLENE
• E203US9158: SUPOLENE
• E203US9157: SUPOLENE
• E203US9156: SUPOLENE
• E203US9155: SUPOLENE
• E203US91526: SUPOLENE
• E203US9152: SUPOLENE
• E203US91514: SUPOLENE
• E203US9148: SUPOLENE
• E203US91426: SUPOLENE
• E203US9132: SUPOLENE
• E203US90616: SUPOLENE
• E203US9038: SUPOLENE
• E203US9028: SUPOLENE
• E203US9027: SUPOLENE
• E203US9026: SUPOLENE
• E203US90231: SUPOLENE
• E203US90230: SUPOLENE
• E203US90225: SUPOLENE
• E203US90223: SUPOLENE
• E203US90220: SUPOLENE
• E203US90219: SUPOLENE
• E203US90214: SUPOLENE
• E203US90210: SUPOLENE