| Primary Device ID | 07640177820501 |
| NIH Device Record Key | c970a46e-0a19-48e5-afa9-445afe34dd03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neo Medical Pedicle screw kit |
| Version Model Number | RE-TH-00-UN |
| Company DUNS | 486778843 |
| Company Name | Neo Medical SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 |
| 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 | 07640177820501 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-03 |
| Device Publish Date | 2022-01-26 |
| 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) |
| 07640177821171 | Iliac connector - 150 mm |
| 07640177821157 | Iliac screw Ø10.0 x 100mm |
| 07640177821140 | Iliac screw Ø10.0 x 90mm |
| 07640177821133 | Iliac screw Ø10.0 x 80mm |
| 07640177821126 | Iliac screw Ø10.0 x 70mm |
| 07640177821065 | Axial connector 5.5mm to 5.5mm |