LATERAL DISTAL FIBULA PLATE, XL, 18-HOLE, LEFT

GUDID 00848665029178

ADVANCED ORTHOPEDIC SOLUTIONS INC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00848665029178
NIH Device Record Key8122c11f-6b76-4743-865e-2c69d5ab6179
Commercial Distribution StatusIn Commercial Distribution
Brand NameLATERAL DISTAL FIBULA PLATE, XL, 18-HOLE, LEFT
Version Model Number3051-018
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665029178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665029178]

Moist Heat or Steam Sterilization


[00848665029178]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-26
Device Publish Date2018-06-25

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