Trial Neck Reacher 37.5-50

GUDID 09348215055530

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215055530
NIH Device Record Key1f4c8040-fec5-4447-889f-ace638fb5a61
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Neck Reacher 37.5-50
Version Model Number111-242-153
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS109348215055530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215055530]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-07
Device Publish Date2019-10-30

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215027179 - Freedom Pedicle Screw System2024-11-07
09348215027186 - Freedom Pedicle Screw System2024-11-07
09348215027193 - Freedom Pedicle Screw System2024-11-07
09348215027209 - Freedom Pedicle Screw System2024-11-07
09348215027216 - Freedom Pedicle Screw System2024-11-07
09348215027223 - Freedom Pedicle Screw System2024-11-07
09348215027230 - Freedom Pedicle Screw System2024-11-07
09348215027247 - Freedom Pedicle Screw System2024-11-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.