PONTiS Flexor Tendon Repair System 400-3011

GUDID 00859210006001

PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO.

PONTIS ORTHOPAEDICS, LLC

Metallic suture, multifilament

• Primary Device ID: 00859210006001
• NIH Device Record Key: 61ecd0f2-5b8d-42f7-9578-537c3f080951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PONTiS Flexor Tendon Repair System
• Version Model Number: 400-3011
• Catalog Number: 400-3011
• Company DUNS: 047775061
• Company Name: PONTIS ORTHOPAEDICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859210006001 [Primary]

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-01

On-Brand Devices [PONTiS Flexor Tendon Repair System]

• 00859210006032: PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use wit
• 00859210006025: PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor
• 00859210006018: PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilat
• 00859210006001: PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.