Primary Device ID | 00191083032542 |
NIH Device Record Key | 55405f50-83b4-4efc-a559-f65f57b43315 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cross-Fuse® II PEEK IBF System |
Version Model Number | 38-A-INSERTER-22 |
Catalog Number | 38-A-INSERTER-22 |
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 | false |
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(906)226-9909 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00191083032542 [Primary] |
GS1 | 00846468049256 [Previous] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
[00191083032542]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-25 |
Device Publish Date | 2022-02-17 |
00191083033761 | Sterilization Case |
00191083033754 | Sterilization Case |
00191083033679 | TRIAL SPACER |
00191083033662 | TRIAL SPACER |
00191083033631 | TRIAL SPACER |
00191083033624 | TRIAL SPACER |
00191083033617 | TRIAL SPACER |
00191083033600 | TRIAL SPACER |
00191083033570 | TRIAL SPACER |
00191083033525 | TRIAL SPACER |
00191083033488 | TRIAL SPACER |
00191083033440 | TRIAL SPACER |
00191083033396 | TRIAL SPACER |
00191083033358 | TAMP |
00191083033341 | SLIDER |
00191083033334 | SLIDER |
00191083033327 | SLIDER |
00191083033310 | SLIDER |
00191083033303 | SLIDER |
00191083033273 | Inserter |
00191083033242 | INSERTER |
00191083033228 | INSERTER |
00191083033167 | L4/L5 TRIAL SPACER, RIGHT |
00191083033150 | L4/L5 TRIAL SPACER, LEFT |
00191083033143 | L4/L5 TRIAL SPACER, RIGHT |
00191083033136 | L4/L5 TRIAL SPACER, LEFT |
00191083033129 | L4/L5 TRIAL SPACER, RIGHT |
00191083033112 | L4/L5 TRIAL SPACER, LEFT |
00191083033105 | L4/L5 TRIAL SPACER, RIGHT |
00191083033099 | L4/L5 TRIAL SPACER, LEFT |
00191083033082 | L4/L5 TRIAL SPACER, RIGHT |
00191083033075 | L4/L5 TRIAL SPACER, LEFT |
00191083032788 | L4/L5 TRIAL SPACER |
00191083032771 | L4/L5 TRIAL SPACER |
00191083032764 | L4/L5 TRIAL SPACER |
00191083032733 | L4/L5 TRIAL SPACER |
00191083032696 | L4/L5 TRIAL SPACER |
00191083032689 | L4/L5 TRIAL SPACER |
00191083032672 | L4/L5 TRIAL SPACER |
00191083032641 | L4/L5 TRIAL SPACER |
00191083032597 | L4/L5 TRIAL SPACER |
00191083032542 | ANGLED INSERTER |
00191083043272 | INTERBODY FUSION DEVICE |
00191083043265 | INTERBODY FUSION DEVICE |
00191083042695 | INTERBODY FUSION DEVICE |
00191083042688 | INTERBODY FUSION DEVICE |
00191083042671 | INTERBODY FUSION DEVICE |
00191083042664 | INTERBODY FUSION DEVICE |
00191083042657 | INTERBODY FUSION DEVICE |
00191083042640 | INTERBODY FUSION DEVICE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CROSS-FUSE 77284786 3544634 Live/Registered |
Pioneer Surgical Technology, Inc. 2007-09-20 |