Parcus Suture Tape 20042

GUDID M685200421

PARCUS MEDICAL LLC

Polyolefin suture, multifilament

• Primary Device ID: M685200421
• NIH Device Record Key: d8d90bfe-f5ce-4431-84fc-011a9b90d097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parcus Suture Tape
• Version Model Number: 20042
• Catalog Number: 20042
• Company DUNS: 859961950
• Company Name: PARCUS MEDICAL LLC
• Device Count: 6
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com
• Phone: 941-755-7965
• Email: CustomerService@ParcusMedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M685200421 [Primary]
HIBCC	M685200429 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153307

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: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-03-08

On-Brand Devices [Parcus Suture Tape]

• M68520042S0: Sterile Parcus Suture Tape
• M685200421: 20042