MIS FUSION Instruments 724-927

GUDID 00191083028200

LATERAL RAKE CURETTE, DOWN BEND

Pioneer Surgical Technology, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00191083028200
NIH Device Record Key5d090c41-af56-44b4-91e5-c898a15b9102
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIS FUSION Instruments
Version Model Number724-927
Catalog Number724-927
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com
Phone+1(386)418-8888
Emaillabeling@rtix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]
GS100191083028200 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


[00191083028200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [MIS FUSION Instruments]

00846468000509MIS FUSION, EXTENDED HANDLE, ASSEMBLY
00846468000493MIS FUS,17mm PADDLE DISTRACTOR, 3.3" OAL
00846468000486MIS FUS,16mm PADDLE DISTRACTOR, 3.3" OAL
00846468000479MIS FUS,15mm PADDLE DISTRACTOR, 3.3" OAL
00846468000462MIS FUS,14mm PADDLE DISTRACTOR, 3.3" OAL
00846468000455MIS FUS,13mm PADDLE DISTRACTOR, 3.3" OAL
00846468000448MIS FUS,12mm PADDLE DISTRACTOR, 3.3" OAL
00846468000431MIS FUS,11mm PADDLE DISTRACTOR, 3.3" OAL
00846468000424MIS FUS,10mm PADDLE DISTRACTOR, 3.3" OAL
00846468000417MIS FUS, 9mm PADDLE DISTRACTOR, 3.3" OAL
00846468000400MIS FUS, 8mm PADDLE DISTRACTOR, 3.3" OAL
00846468000394MIS FUS, 7mm PADDLE DISTRACTOR, 3.3" OAL
00846468000387MIS FUS, 6mm PADDLE DISTRACTOR, 3.3" OAL
00191083028231Shared Spine 15 Deg Bent Osteotome
00191083028095MIS FUSION 17mm PARALLELOGRAM SHAVER
00191083028088MIS FUSION 16mm PARALLELOGRAM SHAVER
00191083028071MIS FUSION 15mm PARALLELOGRAM SHAVER
00191083028064MIS FUSION 14mm PARALLELOGRAM SHAVER
00191083028057MIS FUSION 13mm PARALLELOGRAM SHAVER
00191083028040MIS FUSION 12mm PARALLELOGRAM SHAVER
00191083028033MIS FUSION 11mm PARALLELOGRAM SHAVER
00191083028026MIS FUSION 10mm PARALLELOGRAM SHAVER
00191083028019MIS FUSION 9mm PARALLELOGRAM SHAVER
00191083028002MIS FUSION 8mm PARALLELOGRAM SHAVER
00191083027999MIS FUSION 7mm PARALLELOGRAM SHAVER
00191083027982MIS FUS, FLAT TIP NERVE ROOT RETR, 11mm
00191083027975MIS FUS, FLAT TIP NERVE ROOT RETR, 9mm
00191083027968MIS FUS, FLAT TIP NERVE ROOT RETR, 7mm
00191083027951FUSION MIS 6mm OSTEOTOME
00191083027944MIS FUSION 9mm SUCTION
00191083027937MIS FUSION, 15mm FLAT SHAVER
00191083027920MIS FUSION, 14mm FLAT SHAVER
00191083027913MIS FUSION, 13mm FLAT SHAVER
00191083027906MIS FUSION, 12mm FLAT SHAVER
00191083027890MIS FUSION, 11mm FLAT SHAVER
00191083027883MIS FUSION, 10mm FLAT SHAVER
00191083027876MIS FUSION, 9mm FLAT SHAVER
00191083027869MIS FUSION, 8mm FLAT SHAVER
00191083027852MIS FUSION, 7mm FLAT SHAVER
00191083027845MIS FUSION, 6mm FLAT SHAVER
00191083027838MIS FUSION, 17mm SHARP SHAVER
00191083027821MIS FUSION, 16mm SHARP SHAVER
00191083027814MIS FUSION, 15mm SHARP SHAVER
00191083027807MIS FUSION, 14mm SHARP SHAVER
00191083027791MIS FUSION, 13mm SHARP SHAVER
00191083027784MIS FUSION, 12mm SHARP SHAVER
00191083027777MIS FUSION, 11mm SHARP SHAVER
00191083027760MIS FUSION, 10mm SHARP SHAVER
00191083027753MIS FUSION, 9mm SHARP SHAVER
00191083027746MIS FUSION, 8mm SHARP SHAVER

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