SOT3.5L22

GUDID 03700569613426

NEWCLIP TECHNICS

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03700569613426
NIH Device Record Key1acc0c34-70e8-4099-ac3d-da13820cb008
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSOT3.5L22
Catalog NumberSOT3.5L22
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
GS103700569613426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700569613426]

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

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03700569607609 - Alians Clavicle2024-11-21
03700569608958 - Alians Clavicle2024-11-21
03700569608972 - Alians Clavicle2024-11-21
03700569608989 - Alians Clavicle2024-11-21
03700569608996 - Alians Clavicle2024-11-21

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