Neo Medical Pedicle screw kit

GUDID 07640177820501

Universal T-Handle

Neo Medical SA

Surgical instrument handle, non-torque-limiting
Primary Device ID07640177820501
NIH Device Record Keyc970a46e-0a19-48e5-afa9-445afe34dd03
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Medical Pedicle screw kit
Version Model NumberRE-TH-00-UN
Company DUNS486778843
Company NameNeo Medical SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640177820501 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-03
Device Publish Date2022-01-26

On-Brand Devices [Neo Medical Pedicle screw kit]

B206RD0300ST0Rod kit straight 300 mm (2x)
B206RD0200ST0Rod kit straight 200 mm (2x)
B206RD0160ST0Rod kit straight 160 mm (2x)
B206RD0130ST0Rod kit straight 130 mm (2x)
B206RD0100ST0Rod kit straight 100 mm (2x)
B206RD0090ST0Rod kit straight 90 mm (2x)
B206RD0080ST0Rod kit straight 80 mm (2x)
B206RD0070ST0Rod kit straight 70 mm (2x)
B206RD0060ST0Rod kit straight 60 mm (2x)
B206RD0050ST0Rod kit straight 50 mm (2x)
B206RD0040ST0Rod kit straight 40 mm (2x)
B206RD0035ST0Rod kit straight 35 mm (2x)
B206RD0030ST0Rod kit straight 30 mm (2x)
B206RD0100PB0Rod kit pre-bent 100 mm (2x)
B206RD0090PB0Rod kit pre-bent 90 mm (2x)
B206RD0080PB0Rod kit pre-bent 80 mm (2x)
B206RD0070PB0Rod kit pre-bent 70 mm (2x)
B206RD0060PB0Rod kit pre-bent 60 mm (2x)
B206RD0050PB0Rod kit pre-bent 50 mm (2x)
B206RD0040PB0Rod kit pre-bent 40 mm (2x)
B206RD0040SB0Rod kit S1/L5 40 mm (2x)
B206RD0030SB0Rod kit S1/L5 30 mm (2x)
B206SC7055PE0Pedicle screw kit 2x(Ø7.0 x 55mm)
B206SC7050PE0Pedicle screw kit 2x(Ø7.0 x 50mm)
B206SC7045PE0Pedicle screw kit 2x(Ø7.0 x 45mm)
B206SC7040PE0Pedicle screw kit 2x(Ø7.0 x 40mm)
B206SC7035PE0Pedicle screw kit 2x(Ø7.0 x 35mm)
B206SC6055PE0Pedicle screw kit 2x(Ø6.0 x 55mm)
B206SC6050PE0Pedicle screw kit 2x(Ø6.0 x 50mm)
B206SC6045PE0Pedicle screw kit 2x(Ø6.0 x 45mm)
B206SC6040PE0Pedicle screw kit 2x(Ø6.0 x 40mm)
B206SC6035PE0Pedicle screw kit 2x(Ø6.0 x 35mm)
B206SC5050PE0Pedicle screw kit 2x(Ø5.0 x 50mm)
07640177820037Pedicle screw kit 2x(Ø5.0 x 45mm)
07640177820020Pedicle screw kit 2x(Ø5.0 x 40mm)
07640177820013PEDICLE SCREW KIT 2x(Ø5.0 x 35mm)
07640177820501Universal T-Handle
07640177821201Persuader
17640177821260Granite Screw Guide (US only) (2x)

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