CALCANEAL DROP-IN TRAY

GUDID 00848665037654

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Instrument tray
Primary Device ID00848665037654
NIH Device Record Keyc1b01d9f-237d-47c4-b3e0-6d23cdcec670
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALCANEAL DROP-IN TRAY
Version Model Number9947-000
Company DUNS117858154
Company NameADVANCED ORTHOPAEDIC 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 Usefalse
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

Customer Support Contacts

Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com
Phone3105339966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665037654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


[00848665037654]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-10-21
Device Publish Date2020-06-16

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

00848665028980 - SEMI-TUBULAR PLATE, 13-HOLE2024-11-13
00848665029000 - SEMI-TUBULAR PLATE, 15-HOLE2024-11-13
00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE2024-11-13
00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE2024-11-13
00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE2024-11-13
00848665029048 - STRAIGHT PLATE, 13-HOLE2024-11-13
00848665029055 - STRAIGHT PLATE, 15-HOLE2024-11-13
00848665029062 - STRAIGHT PLATE, 17-HOLE2024-11-13

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