Primary Device ID | 00840019909105 |
NIH Device Record Key | 1dce3646-f624-48eb-aabc-83ea6db4e40f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sure-Lok Extended Tab Pedicle Screw System |
Version Model Number | 48-3000-7540 |
Catalog Number | 48-3000-7540 |
Company DUNS | 079398589 |
Company Name | PRECISION SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840019909105 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
[00840019909105]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2019-04-15 |
00840019922685 | Instrument & Implant Tray (Empty) |
00840019922678 | K-Wire, SS Trocar/Blunt Tip |
00840019922654 | K-Wire, NI Trocar/Blunt Tip |
00840019922647 | K-Wire, NI Trocar/Threaded |
00840019922630 | K-Wire 1.6mm Diameter, Rounded |
00840019922623 | "Perc" Kwire (.062 X 21.0) |
00840019922616 | "Perc" Kwire (.062 X 21.0) |
00840019922609 | cap screw inserter |
00840019922593 | Percutaneous screwdriver |
00840019922579 | Caliper |
00840019922555 | Rod Inserter - bayonneted |
00840019922548 | Bottle Cap Straight |
00840019922531 | Sleeve, Straight |
00840019922517 | Sleeve, All in One |
00840019922692 | Implant Tray (Empty) |
00840019922661 | K-Wire, SS Trocar/Threaded |
00840019922586 | Tab Remover |
00840019922562 | Anti Torque (closed) |
00840019922524 | Bottle Cap Reduction |
00840019909228 | Percutaneous Screw 8.5 X 55mm |
00840019908924 | Percutaneous Screw 5.5 X 30mm |
00840019908917 | Percutaneous Screw 5.5 X 25mm |
00840019909600 | 150mm straight rod |
00840019909594 | 140mm straight rod |
00840019909587 | 130mm straight rod |
00840019909570 | 120mm straight rod |
00840019909563 | 110mm straight rod |
00840019909556 | 100mm straight rod |
00840019909549 | 90mm Straight Rod |
00840019909532 | 80mm Straight Rod |
00840019909525 | 75mm Straight Rod |
00840019909518 | 70mm Straight Rod |
00840019909501 | 65mm Straight Rod |
00840019909495 | 60mm Straight Rod |
00840019909488 | 55mm Straight Rod |
00840019909471 | 50mm Straight Rod |
00840019909464 | 45mm Straight Rod |
00840019909457 | 40mm Straight Rod |
00840019909440 | 35mm Straight Rod |
00840019909433 | 150mm curved rod |
00840019909426 | 140mm curved rod |
00840019909419 | 130mm curved rod |
00840019909402 | 120mm curved rod |
00840019909396 | 110mm curved rod |
00840019909389 | 100mm curved rod |
00840019909372 | 90mm curved rod |
00840019909365 | 80mm curved rod |
00840019909358 | 75mm curved rod |
00840019909341 | 70mm curved rod |
00840019909334 | 65mm curved rod |