3.5mm x 22mm Ti Cortical Screw

GUDID B562TCX350220

WISHBONE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB562TCX350220
NIH Device Record Keyeef02126-25e9-4c61-be9c-0469c4d9e984
Commercial Distribution StatusIn Commercial Distribution
Brand Name3.5mm x 22mm Ti Cortical Screw
Version Model NumberTCX35022
Company DUNS062355158
Company NameWISHBONE MEDICAL, INC.
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 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
HIBCCB562TCX350220 [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 Date2019-11-25
Device Publish Date2019-11-15

On-Brand Devices [3.5mm x 22mm Ti Cortical Screw ]

B562TCX350220TCX35022
B562TCX35022US0TCX35022-US

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