Primary Device ID | B206SC7040PE0 |
NIH Device Record Key | 9ec90f80-14f2-4dc6-8236-7814a4698536 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Neo Medical Pedicle screw kit |
Version Model Number | SC-70-40-PE |
Catalog Number | SC-70-40-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 | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 Millimeter |
Length | 40 Millimeter |
Outer Diameter | 7 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 |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07640177820112 [Primary] |
HIBCC | B206SC7040PE0 [Secondary] |
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 | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-10-27 |
B206RD0300ST0 | Rod kit straight 300 mm (2x) |
B206RD0200ST0 | Rod kit straight 200 mm (2x) |
B206RD0160ST0 | Rod kit straight 160 mm (2x) |
B206RD0130ST0 | Rod kit straight 130 mm (2x) |
B206RD0100ST0 | Rod kit straight 100 mm (2x) |
B206RD0090ST0 | Rod kit straight 90 mm (2x) |
B206RD0080ST0 | Rod kit straight 80 mm (2x) |
B206RD0070ST0 | Rod kit straight 70 mm (2x) |
B206RD0060ST0 | Rod kit straight 60 mm (2x) |
B206RD0050ST0 | Rod kit straight 50 mm (2x) |
B206RD0040ST0 | Rod kit straight 40 mm (2x) |
B206RD0035ST0 | Rod kit straight 35 mm (2x) |
B206RD0030ST0 | Rod kit straight 30 mm (2x) |
B206RD0100PB0 | Rod kit pre-bent 100 mm (2x) |
B206RD0090PB0 | Rod kit pre-bent 90 mm (2x) |
B206RD0080PB0 | Rod kit pre-bent 80 mm (2x) |
B206RD0070PB0 | Rod kit pre-bent 70 mm (2x) |
B206RD0060PB0 | Rod kit pre-bent 60 mm (2x) |
B206RD0050PB0 | Rod kit pre-bent 50 mm (2x) |
B206RD0040PB0 | Rod kit pre-bent 40 mm (2x) |
B206RD0040SB0 | Rod kit S1/L5 40 mm (2x) |
B206RD0030SB0 | Rod kit S1/L5 30 mm (2x) |
B206SC7055PE0 | Pedicle screw kit 2x(Ø7.0 x 55mm) |
B206SC7050PE0 | Pedicle screw kit 2x(Ø7.0 x 50mm) |
B206SC7045PE0 | Pedicle screw kit 2x(Ø7.0 x 45mm) |
B206SC7040PE0 | Pedicle screw kit 2x(Ø7.0 x 40mm) |
B206SC7035PE0 | Pedicle screw kit 2x(Ø7.0 x 35mm) |
B206SC6055PE0 | Pedicle screw kit 2x(Ø6.0 x 55mm) |
B206SC6050PE0 | Pedicle screw kit 2x(Ø6.0 x 50mm) |
B206SC6045PE0 | Pedicle screw kit 2x(Ø6.0 x 45mm) |
B206SC6040PE0 | Pedicle screw kit 2x(Ø6.0 x 40mm) |
B206SC6035PE0 | Pedicle screw kit 2x(Ø6.0 x 35mm) |
B206SC5050PE0 | Pedicle screw kit 2x(Ø5.0 x 50mm) |
07640177820037 | Pedicle screw kit 2x(Ø5.0 x 45mm) |
07640177820020 | Pedicle screw kit 2x(Ø5.0 x 40mm) |
07640177820013 | PEDICLE SCREW KIT 2x(Ø5.0 x 35mm) |
07640177820501 | Universal T-Handle |
07640177821201 | Persuader |
17640177821260 | Granite Screw Guide (US only) (2x) |