Procedure Kit, Straight Compression Plate, 8 hole with 2.7mm Instruments, Ti

GUDID B562PKSCP2708TIUS0

WISHBONE MEDICAL, INC.

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Primary Device IDB562PKSCP2708TIUS0
NIH Device Record Key9dbe9b5f-1a83-477f-abad-65c66c63f73b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcedure Kit, Straight Compression Plate, 8 hole with 2.7mm Instruments, Ti
Version Model NumberPK-SCP2708-TI-US
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB562PKSCP2708TIUS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-17
Device Publish Date2019-09-09

On-Brand Devices [Procedure Kit, Straight Compression Plate, 8 hole with 2.7mm Instruments, Ti ]

B562PKSCP2708TI0PK-SCP2708-TI
B562PKSCP2708TIUS0PK-SCP2708-TI-US
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