PT4.5L52

GUDID 03700569601027

NEWCLIP TECHNICS

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03700569601027
NIH Device Record Key94178f9b-484b-4754-b105-b47e07a15c54
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPT4.5L52
Catalog NumberPT4.5L52
Company DUNS263281904
Company NameNEWCLIP TECHNICS
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS103700569601027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700569601027]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2016-09-28

Devices Manufactured by NEWCLIP TECHNICS

03700569600839 - NA2024-02-19
03700569600846 - NA2024-02-19
03700569600853 - NA2024-02-19
03700569600860 - NA2024-02-19
03700569600877 - NA2024-02-19
03700569600884 - NA2024-02-19
03700569601027 - NA2024-02-19
03700569601027 - NA2024-02-19
03700569601188 - NA2024-02-19

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