PONTiS Flexor Tendon Repair System 400-3014

GUDID 00859210006018

PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilating catheter for tendon transfer and pulley dilation 1x Funnel for tendon transfer 1x SS threader for threading sutures through the catheter & funnel Supplied pouched, sterilized with EO.

PONTIS ORTHOPAEDICS, LLC

Suturing unit, single-use
Primary Device ID00859210006018
NIH Device Record Key3a867bfe-fdc7-49ad-a8e6-79bb70e28476
Commercial Distribution StatusIn Commercial Distribution
Brand NamePONTiS Flexor Tendon Repair System
Version Model Number400-3014
Catalog Number400-3014
Company DUNS047775061
Company NamePONTIS ORTHOPAEDICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com
Phone415-567-8935
Emailinfo@pontisorthopaedics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859210006018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2016-09-01

On-Brand Devices [PONTiS Flexor Tendon Repair System]

00859210006032PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use wit
00859210006025PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor
00859210006018PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilat
00859210006001PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.