Neo Medical Pedicle Screw System

GUDID 07640177821096

Screw Guide Remover

Neo Medical SA

Orthopaedic inorganic implant inserter/extractor, single-use
Primary Device ID07640177821096
NIH Device Record Key892b13b3-481b-404d-98c9-a1e4804ee6c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Medical Pedicle Screw System
Version Model NumberSI-RE-ER-00
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640177821096 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2023-01-26

On-Brand Devices [Neo Medical Pedicle Screw System]

07640177820679Pedicle marker inserter
07640177821188Single Use Pedicle marker (2x)
07640177821256Persuader (US Only)
07640177821232Ratchet T-Handle - 1/4", NS
07640177820884Screwdriver Converter - Hudson, NS
07640177820877Screwdriver Converter - AO, NS
07640177820860Screwdriver Handle, NS
07640177820853Ratchet Screwdriver 1/4", NS
07640177820815Ratchet Handle - 1/4", NS
07640177820808Screwdriver Adaptor - 1/4", NS
07640177820785Screwdriver Adaptor - Hudson, NS
07640177820778Ratchet Handle - Hudson, NS
07640177820433Screw driver Kit
076401778204571.5mm K-wire (1x2)
07640177821225Rod kit pre-bent 45 mm (2x)
07640177821218Rod kit pre-bent 35 mm (2x)
07640177821195Pedicle screw kit 2x(Ø5.0 x 30mm)
07640177821072Revision Guide
07640177821058Pedicle screw kit 2x(Ø8.0 x 40mm)
07640177821041Pedicle screw kit 2x(Ø8.0 x 35mm)
07640177821034Pedicle screw kit 2x(Ø7.0 x 30mm)
07640177821027Pedicle screw kit 2x(Ø6.0 x 30mm)
07640177820839Iliac connector - 70 mm
07640177820822Iliac connector - 40 mm
07640177821096Screw Guide Remover

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