PONTiS Suture-Crimp Implant 400-3019

GUDID 08592110006100

PONTiS Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x #3-0 MFSS suture with 2 straight needles (white wrap) 1x #3-0 MFSS suture with 2 straight needles (black wrap) 1x SS Crimp collar Supplied pouched, sterilized with EO

PONTIS ORTHOPAEDICS, LLC

Metallic suture, multifilament

• Primary Device ID: 08592110006100
• NIH Device Record Key: 6e29a264-be36-40de-836c-d301153a3553
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PONTiS Suture-Crimp Implant
• Version Model Number: 400-3019
• Catalog Number: 400-3019
• 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

Customer Support Contacts

• Phone: 415-567-8935
• Email: info@pontisorthopaedics.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592110006100 [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: 2016-11-18

On-Brand Devices [PONTiS Suture-Crimp Implant]

• 00859210006117: PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Eac
• 08592110006100: PONTiS Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit