Neo Medical Pedicle Screw System

GUDID 07640177820679

Pedicle marker inserter

Neo Medical SA

Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic Bone tack inserter, basic
Primary Device ID07640177820679
NIH Device Record Keyb6fc4342-9f56-4beb-8b7c-7076ff07d080
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Medical Pedicle Screw System
Version Model NumberSI-PM-IN-NS
Company DUNS486778843
Company NameNeo Medical SA
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640177820679 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


[07640177820679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

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)

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