Primary Device ID | 00840916143091 |
NIH Device Record Key | 78616247-6f57-46e3-be50-0a3675bac025 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PIRANHA |
Version Model Number | CSVS-425-18 |
Company DUNS | 004022104 |
Company Name | SPINAL ELEMENTS |
Device Count | 1 |
DM Exempt | false |
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 | true |
Serial Number | false |
Manufacturing Date | true |
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 | 00840916143091 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
[00840916143091]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-01-18 |
Device Publish Date | 2021-01-09 |
00840916112752 | Piranha, Rescue Variable Screw Ø 4.25mmx14mm |
00840916112745 | Piranha, Rescue Variable Screw Ø 4.25mm x 12mm |
00840916112738 | Piranha, Self Drilling Variable Screw Ø 4.0mmx18mm |
00840916112721 | Piranha, Self Drilling Variable Screw Ø 4.0mmx16mm |
00840916112714 | Piranha, Self Drilling Variable Screw Ø 4.0mmx14mm |
00840916112707 | Piranha, Self Drilling Variable Screw Ø 4.0mmx12mm |
00840916112691 | Piranha Cervical Screw Ø 4.25mm x 12mm |
00840916112684 | Piranha Cervical Variable Screw Ø 4.25mm x 16mm |
00840916112677 | Piranha Cervical Variable Screw Ø 4.25mm x 14mm |
00840916112660 | Piranha Cervical Variable Screw Ø 4.25mm x 12mm |
00840916112653 | Piranha Cervical Variable Screw Ø 4.0mm x 18mm |
00840916112646 | Piranha Cervical Variable Screw Ø 4.0mm x 16mm |
00840916112639 | Piranha Cervical Variable Screw Ø 4.0mm x 14mm |
00840916112622 | Piranha Variable Screw Ø 4.0mm x 12mm |
00840916112615 | Piranha Cervical Screw Ø 4.25mm x 18mm |
00840916112608 | Piranha Cervical Screw Ø 4.25mm x 16mm |
00840916112592 | Piranha Cervical Screw Ø 4.25mm x 14mm |
00840916112585 | Piranha Cervical Screw Ø 4.25mm x 12mm |
00840916112578 | Piranha Cervical Screw Ø 4.0mm x 18mm |
00840916112561 | Piranha Cervical Screw Ø 4.0mm x 16mm |
00840916112554 | Piranha Cervical Screw Ø 4.0mm x 14mm |
00840916112547 | Piranha Cervical Screw Ø 4.0mm x 12mm |
00840916156695 | QC PIRANHA DRIVER |
00840916156602 | PIRANHA STAB AND GRAB DRIVER |
00840916156596 | PIRANHA SWIVEL-TOP SCREWDRIVER |
00840916156589 | PIRANHA EXTRA LONG AO DRIVER |
00840916156572 | PIRANHA SCREW CADDY |
00840916156558 | PIRANHA TEMPORARY FIXATION PIN INSERTER |
00840916156527 | 9MM AWLS |
00840916156466 | VARIABLE CERVICAL DRILL GUIDE |
00840916156459 | PIRANHA SCREW CADDY |
00840916156442 | PIRANHA SET 4 LEVEL CADDY |
00840916156435 | PIRANHA SET 3 LEVEL CADDY |
00840916156428 | PIRANHA SET 2 LEVEL CADDY |
00840916156411 | PIRANHA SET 1 LEVEL CADDY |
00840916156404 | DOUBLE BARREL DRILL GUIDE |
00840916156299 | 10 MM DRILL BITSHAFT |
00840916156282 | 10 MM DRILL BIT |
00840916150983 | CERVICAL PLATE HEX DRIVER |
00840916143152 | CERVICAL PLATE HOLDER |
00840916143138 | CERVICAL PLATE BENDER |
00840916143091 | Piranha, Rescue Variable Screw Ø 4.25mmx18mm |
00840916143084 | Piranha, Rescue Variable Screw Ø 4.25mmx16mm |
00840916143220 | Piranha Solid Drill Guide |
00840916143213 | Piranha Screw Caddy Platform |
00840916143206 | Bone Awl |
00840916143190 | Plate Shield Driver |
00840916143183 | Cervical Marker Screw |
00840916143176 | Piranha Hex Driver Stab & Grab Tip |
00840916143169 | Cervical Mini-Ratchet Handle (G130150) |