CT3.5L55

GUDID 03700569612313

NEWCLIP TECHNICS

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03700569612313
NIH Device Record Key4ddeb922-4da4-4242-aa21-afd53b272607
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCT3.5L55
Catalog NumberCT3.5L55
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
GS103700569612313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700569612313]

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
03700569601188 - NA2024-02-19

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