Distal Hook Plate, Short, 3-Hole

GUDID 00848665024753

ADVANCED ORTHOPEDIC SOLUTIONS INC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00848665024753
NIH Device Record Key853b262a-8aa8-4011-9761-46e0f5529400
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Hook Plate, Short, 3-Hole
Version Model Number3043-003
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS 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 Datefalse
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
GS100848665024753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665024753]

Moist Heat or Steam Sterilization


[00848665024753]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-01

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