COUNTERSINK

GUDID 00848665027679

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665027679
NIH Device Record Keye0656a1c-fd58-4d07-84b9-1494fb480828
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOUNTERSINK
Version Model Number4006-000
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]
GS100848665027679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone
HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


[00848665027679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

00848665027679 - COUNTERSINK2020-06-23
00848665027679 - COUNTERSINK2020-06-23
00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm2020-06-08
00848665001235 - AOS CANCELLOUS TAP 3.5mm2020-06-08
00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH2020-06-08
00848665028041 - T10 Screwdriver, Short2020-06-08
00848665028096 - 3.5mm Calibrated Drill2020-06-08
00848665028119 - AOS 2.6mm Solid Reamer2020-06-08
00848665028782 - T10 Screwdriver, Solid2020-06-08

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