BDT2.0L18 BDT2.0L18

GUDID 03700569601362

NEWCLIP TECHNICS

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID03700569601362
NIH Device Record Key54a8d74f-5841-4214-9141-c186446e527b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBDT2.0L18
Version Model NumberBDT2.0L18
Catalog NumberBDT2.0L18
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 Datetrue
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
GS103700569601362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700569601362]

Moist Heat or Steam Sterilization


[03700569601362]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-18
Device Publish Date2019-04-10

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