Primary Device ID | 07640177821058 |
NIH Device Record Key | 65ceb5d5-9fa0-435d-a21e-2405b2dce08a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Neo Medical Pedicle Screw System |
Version Model Number | SC-80-40-PE |
Company DUNS | 486778843 |
Company Name | Neo Medical SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 8 Millimeter |
Length | 40 Millimeter |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640177821058 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-07-22 |
Device Publish Date | 2023-01-20 |
07640177820679 | Pedicle marker inserter |
07640177821188 | Single Use Pedicle marker (2x) |
07640177821256 | Persuader (US Only) |
07640177821232 | Ratchet T-Handle - 1/4", NS |
07640177820884 | Screwdriver Converter - Hudson, NS |
07640177820877 | Screwdriver Converter - AO, NS |
07640177820860 | Screwdriver Handle, NS |
07640177820853 | Ratchet Screwdriver 1/4", NS |
07640177820815 | Ratchet Handle - 1/4", NS |
07640177820808 | Screwdriver Adaptor - 1/4", NS |
07640177820785 | Screwdriver Adaptor - Hudson, NS |
07640177820778 | Ratchet Handle - Hudson, NS |
07640177820433 | Screw driver Kit |
07640177820457 | 1.5mm K-wire (1x2) |
07640177821225 | Rod kit pre-bent 45 mm (2x) |
07640177821218 | Rod kit pre-bent 35 mm (2x) |
07640177821195 | Pedicle screw kit 2x(Ø5.0 x 30mm) |
07640177821072 | Revision Guide |
07640177821058 | Pedicle screw kit 2x(Ø8.0 x 40mm) |
07640177821041 | Pedicle screw kit 2x(Ø8.0 x 35mm) |
07640177821034 | Pedicle screw kit 2x(Ø7.0 x 30mm) |
07640177821027 | Pedicle screw kit 2x(Ø6.0 x 30mm) |
07640177820839 | Iliac connector - 70 mm |
07640177820822 | Iliac connector - 40 mm |