Duramesh

GUDID 10850008298100

DURAMESH™ 1 Mesh Suture: Small Needle – USA

Mesh Suture Inc.

Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 10850008298100
• NIH Device Record Key: db91373c-4346-4fe1-8065-8aa2c3303f31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duramesh
• Version Model Number: MSI-300
• Company DUNS: 116375032
• Company Name: Mesh Suture Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00850008298103 [Primary]
GS1	10850008298100 [Package]; Contains: 00850008298103; Package: Shrink wrap sleeve [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211178

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [Duramesh]

• 10850008298131: DURAMESH™ 2 Mesh Suture: Large Needle – USA
• 10850008298124: DURAMESH™ 2 Mesh Suture: Small Needle – USA
• 10850008298117: DURAMESH™ 1 Mesh Suture: Large Needle – USA
• 10850008298100: DURAMESH™ 1 Mesh Suture: Small Needle – USA
• 10850008298094: DURAMESH™ 0 Mesh Suture: Large Needle – USA
• 00850008298080: DURAMESH™ 0 Mesh Suture: Small Needle – USA
• 00850008298073: DURAMESH™ 2-0 Mesh Suture: Small Needle – USA