PONTiS Achilles Tendon Repair System 600-4001

GUDID 00859210006070

PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 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 ID00859210006070
NIH Device Record Key93cd59fc-c656-45e8-9757-5007351a9220
Commercial Distribution StatusIn Commercial Distribution
Brand NamePONTiS Achilles Tendon Repair System
Version Model Number600-4001
Catalog Number600-4001
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100859210006070 [Primary]

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 Number3
Public Version Date2019-05-07
Device Publish Date2016-09-01

Devices Manufactured by PONTIS ORTHOPAEDICS, LLC

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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 System2019-05-07PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3 MFSS suture with 2 curved needles (white wrap) 1x size #3 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar for #3 SS sutures Supplied pouched, sterilized with EO.
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 System2018-03-29 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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