Primary Device ID | 00191083028040 |
NIH Device Record Key | 9e56669a-d598-4216-a7f9-3b053f57e727 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MIS FUSION Instruments |
Version Model Number | 724-608 |
Catalog Number | 724-608 |
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 |
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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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Device Issuing Agency | Device ID |
---|---|
GS1 | 00191083028040 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
Moist Heat or Steam Sterilization
[00191083028040]
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 |
00846468000509 | MIS FUSION, EXTENDED HANDLE, ASSEMBLY |
00846468000493 | MIS FUS,17mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000486 | MIS FUS,16mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000479 | MIS FUS,15mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000462 | MIS FUS,14mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000455 | MIS FUS,13mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000448 | MIS FUS,12mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000431 | MIS FUS,11mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000424 | MIS FUS,10mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000417 | MIS FUS, 9mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000400 | MIS FUS, 8mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000394 | MIS FUS, 7mm PADDLE DISTRACTOR, 3.3" OAL |
00846468000387 | MIS FUS, 6mm PADDLE DISTRACTOR, 3.3" OAL |
00191083028231 | Shared Spine 15 Deg Bent Osteotome |
00191083028095 | MIS FUSION 17mm PARALLELOGRAM SHAVER |
00191083028088 | MIS FUSION 16mm PARALLELOGRAM SHAVER |
00191083028071 | MIS FUSION 15mm PARALLELOGRAM SHAVER |
00191083028064 | MIS FUSION 14mm PARALLELOGRAM SHAVER |
00191083028057 | MIS FUSION 13mm PARALLELOGRAM SHAVER |
00191083028040 | MIS FUSION 12mm PARALLELOGRAM SHAVER |
00191083028033 | MIS FUSION 11mm PARALLELOGRAM SHAVER |
00191083028026 | MIS FUSION 10mm PARALLELOGRAM SHAVER |
00191083028019 | MIS FUSION 9mm PARALLELOGRAM SHAVER |
00191083028002 | MIS FUSION 8mm PARALLELOGRAM SHAVER |
00191083027999 | MIS FUSION 7mm PARALLELOGRAM SHAVER |
00191083027982 | MIS FUS, FLAT TIP NERVE ROOT RETR, 11mm |
00191083027975 | MIS FUS, FLAT TIP NERVE ROOT RETR, 9mm |
00191083027968 | MIS FUS, FLAT TIP NERVE ROOT RETR, 7mm |
00191083027951 | FUSION MIS 6mm OSTEOTOME |
00191083027944 | MIS FUSION 9mm SUCTION |
00191083027937 | MIS FUSION, 15mm FLAT SHAVER |
00191083027920 | MIS FUSION, 14mm FLAT SHAVER |
00191083027913 | MIS FUSION, 13mm FLAT SHAVER |
00191083027906 | MIS FUSION, 12mm FLAT SHAVER |
00191083027890 | MIS FUSION, 11mm FLAT SHAVER |
00191083027883 | MIS FUSION, 10mm FLAT SHAVER |
00191083027876 | MIS FUSION, 9mm FLAT SHAVER |
00191083027869 | MIS FUSION, 8mm FLAT SHAVER |
00191083027852 | MIS FUSION, 7mm FLAT SHAVER |
00191083027845 | MIS FUSION, 6mm FLAT SHAVER |
00191083027838 | MIS FUSION, 17mm SHARP SHAVER |
00191083027821 | MIS FUSION, 16mm SHARP SHAVER |
00191083027814 | MIS FUSION, 15mm SHARP SHAVER |
00191083027807 | MIS FUSION, 14mm SHARP SHAVER |
00191083027791 | MIS FUSION, 13mm SHARP SHAVER |
00191083027784 | MIS FUSION, 12mm SHARP SHAVER |
00191083027777 | MIS FUSION, 11mm SHARP SHAVER |
00191083027760 | MIS FUSION, 10mm SHARP SHAVER |
00191083027753 | MIS FUSION, 9mm SHARP SHAVER |
00191083027746 | MIS FUSION, 8mm SHARP SHAVER |