Xpert Wrist H1.3BDT2.4L26

GUDID 03700569640613

NEWCLIP TECHNICS

Orthopaedic bone screw (non-sliding)
Primary Device ID03700569640613
NIH Device Record Key03cac5ef-98be-4053-bf58-9dde54a5fed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert Wrist
Version Model NumberH1.3BDT2.4L26
Catalog NumberH1.3BDT2.4L26
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
GS103700569640613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


[03700569640613]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-22
Device Publish Date2024-11-14

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
03700569664909KIT-WRNS2G
03700569664893KIT-WRNS2D
03700569664886KIT-WR2G
03700569664879KIT-WR2D
03700569664862KIT-WQ2G
03700569664855KIT-WQ2D
03700569664848KIT-WHE2G
03700569664831KIT-WHE2D
03700569664824KIT-WHE1G
03700569664800KIT-WEL2S
03700569664794KIT-WEF2G
03700569664787KIT-WEF2D
03700569664763KIT-FSRNS2G
03700569664756KIT-FSRNS2D
03700569664749KIT-FSR2G
03700569664732KIT-FSR2D
03700569664725KIT-FSQ2G
03700569664718KIT-FSQ2D
03700569664701KIT-FSHE2G
03700569664695KIT-FSHE2D
03700569664688KIT-FSHE1G
03700569664671KIT-FSHE1D
03700569664664KIT-FSEL2S
03700569664657KIT-FSEF2G
03700569664640KIT-FSEF2D
03700569658243KIT-XEW1G

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.