OIC External Fixation System

GUDID 10811998038398

4MM X 20MM SELF TAPPING HALF PIN

ORTHOPAEDIC IMPLANT COMPANY, THE

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID10811998038398
NIH Device Record Key4781f46e-c6d6-4326-b486-4e699de5a2f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOIC External Fixation System
Version Model NumberSTHP-0420
Company DUNS070061160
Company NameORTHOPAEDIC IMPLANT COMPANY, THE
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

Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com
Phone775 636 8281
EmailInfo@OrthoImplantCompany.com

Device Dimensions

Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110811998038398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

[10811998038398]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2018-07-31

On-Brand Devices [OIC External Fixation System]

208119980383265MM PIN COVER
108119980585702.4MM X 140MM CALIBRATED STEP DRILL
108119980485643MM SELF TAPPING HALF PIN, 15MM THREAD LENGTH, 110MM LONG
10811998038558MULTI-HOLE PIN CLAMP, 8 HOLE
M69601EXF000STERILIZATION CASE
10811998038206STERILIZATION CASE
108119980385722.4MM X 140MM CALIBRATED STEP DRILL
108119980385653MM SELF TAPPING HALF PIN, 15MM THREAD LENGTH, 110MM LONG
M696XBR11600011MM X 600MM CARBON BAR
M696XBR11550011MM X 550MM CARBON BAR
M696XBR11500011MM X 500MM CARBON BAR
M696XBR11450011MM X 450MM CARBON BAR
M696XBR11400011MM X 400MM CARBON BAR
M696XBR11350011MM X 350MM CARBON BAR
M696XBR11300011MM X 300MM CARBON BAR
M696XBR11250011MM X 250MM CARBON BAR
M696XBR11200011MM X 200MM CARBON BAR
M696XBR11150011MM X 150MM CARBON BAR
M696XBR11100011MM X 100MM CARBON BAR
M696EXFP90090 DEGREE ANGLED POST
M696EXFP30030 DEGREE ANGLED POST
M696EXFP000STRAIGHT POST
M696EXFMC050MULTI-HOLE PIN CLAMP, 5 HOLE
M696EXFC11050COMBINATION CLAMP
M696CAP052515MM PIN COVER
1081199803854111MM X 600MM CARBON BAR
1081199803853411MM X 500MM CARBON BAR
1081199803852711MM X 450MM CARBON BAR
1081199803851011MM X 400MM CARBON BAR
1081199803850311MM X 350MM CARBON BAR
1081199803849711MM X 300MM CARBON BAR
1081199803848011MM X 250MM CARBON BAR
1081199803847311MM X 200MM CARBON BAR
1081199803846611MM X 150MM CARBON BAR
1081199803838130 DEGREE ANGLED POST
10811998038374STRAIGHT POST
10811998038367MULTI-HOLE PIN CLAMP, 5 HOLE
10811998038350COMBINATION CLAMP
108119980385963MM SELF TAPPING HALF PIN, 20MM THREAD LENGTH
M696TFP0525005MM TRANSFIXATION PIN
M696STHP0565L05MM X 65MM SELF TAPPING HALF PIN
M696STHP0555L05MM X 55MM SELF TAPPING HALF PIN
M696STHP0545M05MM X 45MM SELF TAPPING HALF PIN
M696STHP0535M05MM X 35MM SELF TAPPING HALF PIN
M696STHP043004MM X 30MM SELF TAPPING HALF PIN
M696STHP042004MM X 20MM SELF TAPPING HALF PIN
M696BTHP0565L05MM X 65MM BLUNT TIPPED HALF PIN
M696BTHP0555L05MM X 55MM BLUNT TIPPED HALF PIN
M696BTHP0545M05MM X 45MM BLUNT TIPPED HALF PIN
M696BTHP0535M05MM X 35MM BLUNT TIPPED HALF PIN
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