Procedure Kit, Stepped 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti

GUDID B562PKEFS0212T0

WISHBONE MEDICAL, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device IDB562PKEFS0212T0
NIH Device Record Keybce1111b-3d11-444a-9146-9036851f73e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Kit, Stepped 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti
Version Model NumberPK-EFS0212T
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 Kittrue
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
HIBCCB562PKEFS0212T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-18
Device Publish Date2019-09-10

On-Brand Devices [Procedure Kit, Stepped 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti]

B562PKEFS0212TUS0PK-EFS0212T-US
B562PKEFS0212T0PK-EFS0212T

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