Xpert Wrist BDT1.8L22-ST

GUDID 03700569642389

NEWCLIP TECHNICS

Orthopaedic bone screw (non-sliding)
Primary Device ID03700569642389
NIH Device Record Key0306d778-1249-4bb2-a3bc-fe74752aa4b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert Wrist
Version Model NumberBDT1.8L22-ST
Catalog NumberBDT1.8L22-ST
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103700569642389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

On-Brand Devices [Xpert Wrist]

03700569654382CAT3.5L18D-ST
03700569654375CAT3.5L18D
03700569654368CAT3.5L16D-ST
03700569654351CAT3.5L16D
03700569654344CAT3.5L14D-ST
03700569654337CAT3.5L14D
03700569654320CAT3.5L12D-ST
03700569654313CAT3.5L12D
03700569654306CAT3.5L10D-ST
03700569654290CAT3.5L10D
03700569642402BDT1.8L26-ST
03700569642396BDT1.8L24-ST
03700569642389BDT1.8L22-ST
03700569642372BDT1.8L20-ST
03700569642365BDT1.8L18-ST
03700569642358BDT1.8L16-ST
03700569642341BDT1.8L14-ST
03700569642334BDT1.8L26
03700569642327BDT1.8L24
03700569642310BDT1.8L22
03700569642303BDT1.8L20
03700569642297BDT1.8L18
03700569642280BDT1.8L16
03700569642273BDT1.8L14

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