Primary Device ID | G079C25200A0600 |
NIH Device Record Key | 25d8989f-0a65-4607-8c70-5ee638a00582 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MIS Golden Isles Pedicle Screw System |
Version Model Number | C25-200A-060 |
Company DUNS | 037368183 |
Company Name | Intelivation, LLC |
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 | 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 |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Length | 60 Millimeter |
Outer Diameter | 5.5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G079C25200A0600 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
[G079C25200A0600]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-05 |
Device Publish Date | 2023-04-27 |
G079C511000A020 | MIS Reduction Headbody |
G079C510000A030 | MIS Extended Tab |
G079C25200A300 | Ø5.5mm MIS Curved Rod, 30mm |
G079C25200A2500 | Ø5.5mm MIS Curved Rod, 250mm |
G079C25200A2400 | Ø5.5mm MIS Curved Rod, 240mm |
G079C25200A2300 | Ø5.5mm MIS Curved Rod, 230mm |
G079C25200A2200 | Ø5.5mm MIS Curved Rod, 220mm |
G079C25200A2100 | Ø5.5mm MIS Curved Rod, 210mm |
G079C25200A2000 | Ø5.5mm MIS Curved Rod, 200mm |
G079C25200A1900 | Ø5.5mm MIS Curved Rod, 190mm |
G079C25200A1800 | Ø5.5mm MIS Curved Rod, 180mm |
G079C25200A1700 | Ø5.5mm MIS Curved Rod, 170mm |
G079C25200A1600 | Ø5.5mm MIS Curved Rod, 160mm |
G079C25200A1500 | Ø5.5mm MIS Curved Rod, 150mm |
G079C25200A1400 | Ø5.5mm MIS Curved Rod, 140mm |
G079C25200A1300 | Ø5.5mm MIS Curved Rod, 130mm |
G079C25200A1200 | Ø5.5mm MIS Curved Rod, 120mm |
G079C25200A1100 | Ø5.5mm MIS Curved Rod, 110mm |
G079C25200A1000 | Ø5.5mm MIS Curved Rod, 100mm |
G079C25200A0950 | Ø5.5mm MIS Curved Rod, 95mm |
G079C25200A0900 | Ø5.5mm MIS Curved Rod, 90mm |
G079C25200A0850 | Ø5.5mm MIS Curved Rod, 85mm |
G079C25200A0800 | Ø5.5mm MIS Curved Rod, 80mm |
G079C25200A0750 | Ø5.5mm MIS Curved Rod, 75mm |
G079C25200A0700 | Ø5.5mm MIS Curved Rod, 70mm |
G079C25200A0650 | Ø5.5mm MIS Curved Rod, 65mm |
G079C25200A0600 | Ø5.5mm MIS Curved Rod, 60mm |
G079C25200A0550 | Ø5.5mm MIS Curved Rod, 55mm |
G079C25200A0500 | Ø5.5mm MIS Curved Rod, 50mm |
G079C25200A0450 | Ø5.5mm MIS Curved Rod, 45mm |
G079C25200A0400 | Ø5.5mm MIS Curved Rod, 40mm |
G079C25200A0350 | Ø5.5mm MIS Curved Rod, 35mm |
G070C511000A010 | MIS Standard Headbody |
G079C50800000220 | K-wire 45mm screw Standard Driver |
G079CC5080000010 | Modified MIS Driver |
G079CC5030000090 | Modified Reduction Driver |
G079C5080000210 | Impaction Cap |
G079C5080000200 | Shorter Driver |
G079C5080000160 | Set Screw Shaft C/D |
G079C5080000110 | MIS Rod Holder |
G079C5080000090 | Screw Depth Measuring Instrument |
G079C5080000080 | MIS Tab Breaker |
G079C5080000070 | MIS Counter Torque Proximal |
G079C5080000060 | Rod Indicator |
G079C5080000050 | MIS Counter Torque Distal |
G079C5080000040 | MIS Final Tightener shaft |
G079C5080000030 | MIS Provisional Locking Cap Driver |
G079C5080000020 | MIS Tab Inserter |
G079C5080000010 | MIS Driver |
G079C500000A02C0 | GI MIS Screw Caddy |