PONTiS Flexor Tendon Repair System 401-3006

GUDID 00859210006032

PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures. 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 ID00859210006032
NIH Device Record Key8277592a-2da5-4f7b-99c3-18532c572e1d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePONTiS Flexor Tendon Repair System
Version Model Number401-3006
Catalog Number401-3006
Company DUNS047775061
Company NamePONTIS ORTHOPAEDICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100859210006032 [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 Number4
Public Version Date2019-05-07
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.
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