PONTiS Flexor Tendon Repar System 400-3015

GUDID 00859210006049

PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile.

PONTIS ORTHOPAEDICS, LLC

Orthopaedic trocar blade, reusable
Primary Device ID00859210006049
NIH Device Record Key337590e8-ff06-454b-a312-0f3290baaad9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePONTiS Flexor Tendon Repar System
Version Model Number400-3015
Catalog Number400-3015
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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@pontisorthopaedic.com

Device Dimensions

Outer Diameter0.063 Inch
Outer Diameter0.063 Inch
Outer Diameter0.063 Inch
Outer Diameter0.063 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100859210006049 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00859210006049]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

Devices Manufactured by PONTIS ORTHOPAEDICS, LLC

00859210006018 - PONTiS Flexor Tendon Repair System2020-02-06 PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader Kit Each Kit contains: 1x Dilating catheter for tendon transfer
08592110006100 - PONTiS Suture-Crimp Implant2019-05-07 PONTiS Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x #3-0 MFSS suture w
00859210006001 - PONTiS Flexor Tendon Repair System2019-05-07 PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0
00859210006032 - PONTiS Flexor Tendon Repair System2019-05-07 PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament
00859210006070 - PONTiS Achilles Tendon Repair System2019-05-07 PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3
00859210006117 - PONTiS Suture-Crimp Implant2019-05-07 PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x Dual #3-0 MFS
00859210006025 - PONTiS Flexor Tendon Repair System2019-03-21 PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has si
00859210006049 - PONTiS Flexor Tendon Repar System2018-03-29PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile.
00859210006049 - PONTiS Flexor Tendon Repar System2018-03-29 PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-
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