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 Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament Metallic suture, multifilament 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.