Primary Device ID | 00846468008840 |
NIH Device Record Key | 98eaac59-68ef-46db-afc4-bfdd2355c82e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | T-Plus PEEK IBF System |
Version Model Number | 30-T-TRL-12L |
Catalog Number | 30-T-TRL-12L |
Company DUNS | 793384496 |
Company Name | Pioneer Surgical Technology, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
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Phone | +1(386)418-8888 |
labeling@rtix.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
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Phone | +1(906)226-9909 |
labeling@resolvesurg.com | |
Phone | +1(906)226-9909 |
labeling@resolvesurg.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00846468008840 [Primary] |
HWT | TEMPLATE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
[00846468008840]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-05 |
Device Publish Date | 2020-09-25 |
00846468033521 | TRIAL SPACER |
00846468033491 | TRIAL SPACER |
00846468033460 | TRIAL SPACER |
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00846468033194 | TRIAL SPACER |
00846468033156 | CRESCENT TAMP |
00846468033149 | SLAP HAMMER |
00846468033101 | INSERTER |
00846468062743 | Tricortical Cancellous Wedge Inserter with Stop |
00846468062736 | Tricortical Cancellous Wedge Inserter |
00846468011093 | TRIAL SPACER, STRAIGHT |
00846468009205 | LONG TRIAL SPACER |
00846468009113 | TRIAL SPACER, STRAIGHT |
00846468009083 | LONG TRIAL SPACER |
00846468008994 | TRIAL SPACER, STRAIGHT |
00846468008963 | LONG TRIAL SPACER |
00846468008901 | TRIAL SPACER, STRAIGHT |
00846468008840 | LONG TRIAL SPACER |
00846468008789 | TRIAL SPACER, STRAIGHT |
00846468008758 | LONG TRIAL SPACER |
00846468008680 | TRIAL SPACER, STRAIGHT |
00846468008659 | LONG TRIAL SPACER |
00846468008345 | TRIAL SPACER, STRAIGHT |
00846468008314 | LONG TRIAL SPACER |
00846468008253 | TRIAL SPACER, STRAIGHT |
00846468008192 | LONG TRIAL SPACER |
00846468008130 | TRIAL SPACER, STRAIGHT |
00846468008109 | LONG TRIAL SPACER |
00846468007720 | LONG STRAIGHT TAMP |
00846468007515 | LONG "L" TAMP |
00846468007478 | LONG CRESCENT TAMP |
00846468007386 | STRAIGHT INSERTER |
00846468007348 | LONG INSERTER |
00846468007317 | INSERTER, MODULAR CLEANING |
00191083025711 | VBR, T+ Pistol Grip Inserter Assembly |
00191083025674 | T-Plus Straight Inserter Special |
00846468088705 | INTERBODY FUSION DEVICE |