6.5 and 7.3mm Large Fragment Cannulated Screw System 00-1402-7105

GUDID 00840194406277

7.3mm Cannulated Screw, 16mm Short Thread,105mm SS

ORTHOPEDIATRICS CORP.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00840194406277
NIH Device Record Key1a38d9d1-43f2-4acf-9d9c-c31b6b0f3388
Commercial Distribution StatusIn Commercial Distribution
Brand Name6.5 and 7.3mm Large Fragment Cannulated Screw System
Version Model Number00-1402-7105
Catalog Number00-1402-7105
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com
Phone+1(574)268-6379
Emailxxx@xxx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194406277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

[00840194406277]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-01
Device Publish Date2021-05-24

On-Brand Devices [6.5 and 7.3mm Large Fragment Cannulated Screw System]

008401944076636.5mm Cannulated Screw, 32mm Long Thread,90mm SS
008401944076566.5mm Cannulated Screw, 32mm Long Thread,88mm SS
008401944076496.5mm Cannulated Screw, 32mm Long Thread,86mm SS
008401944076326.5mm Cannulated Screw, 32mm Long Thread,85mm SS
008401944076256.5mm Cannulated Screw, 32mm Long Thread,84mm SS
008401944076186.5mm Cannulated Screw, 32mm Long Thread,82mm SS
008401944076016.5mm Cannulated Screw, 32mm Long Thread,80mm SS
008401944075956.5mm Cannulated Screw, 32mm Long Thread,78mm SS
008401944075886.5mm Cannulated Screw, 32mm Long Thread,76mm SS
008401944075716.5mm Cannulated Screw, 32mm Long Thread,75mm SS
008401944075646.5mm Cannulated Screw, 32mm Long Thread,74mm SS
008401944075576.5mm Cannulated Screw, 32mm Long Thread,72mm SS
008401944075406.5mm Cannulated Screw, 32mm Long Thread,70mm SS
008401944075336.5mm Cannulated Screw, 32mm Long Thread,68mm SS
008401944075266.5mm Cannulated Screw, 32mm Long Thread,66mm SS
008401944075196.5mm Cannulated Screw, 32mm Long Thread,65mm SS
008401944075026.5mm Cannulated Screw, 32mm Long Thread,64mm SS
008401944074966.5mm Cannulated Screw, 32mm Long Thread,62mm SS
008401944074896.5mm Cannulated Screw, 32mm Long Thread,60mm SS
008401944074726.5mm Cannulated Screw, 32mm Long Thread,58mm SS
008401944074656.5mm Cannulated Screw, 32mm Long Thread,56mm SS
008401944074586.5mm Cannulated Screw, 32mm Long Thread,55mm SS
008401944074416.5mm Cannulated Screw, 32mm Long Thread,54mm SS
008401944074346.5mm Cannulated Screw, 32mm Long Thread,52mm SS
008401944074276.5mm Cannulated Screw, 32mm Long Thread,50mm SS
008401944074106.5mm Cannulated Screw, 32mm Long Thread,48mm SS
008401944074036.5mm Cannulated Screw, 32mm Long Thread,46mm SS
008401944073976.5mm Cannulated Screw, 32mm Long Thread,45mm SS
008401944073806.5mm Cannulated Screw, 32mm Long Thread,44mm SS
008401944073736.5mm Cannulated Screw, 16mm Short Thread,150mm SS
008401944073666.5mm Cannulated Screw, 16mm Short Thread,148mm SS
008401944073596.5mm Cannulated Screw, 16mm Short Thread,146mm SS
008401944073426.5mm Cannulated Screw, 16mm Short Thread,145mm SS
008401944073356.5mm Cannulated Screw, 16mm Short Thread,144mm SS
008401944073286.5mm Cannulated Screw, 16mm Short Thread,142mm SS
008401944073116.5mm Cannulated Screw, 16mm Short Thread,140mm SS
008401944073046.5mm Cannulated Screw, 16mm Short Thread,138mm SS
008401944072986.5mm Cannulated Screw, 16mm Short Thread,136mm SS
008401944072816.5mm Cannulated Screw, 16mm Short Thread,135mm SS
008401944072746.5mm Cannulated Screw, 16mm Short Thread,134mm SS
008401944072676.5mm Cannulated Screw, 16mm Short Thread,132mm SS
008401944072506.5mm Cannulated Screw, 16mm Short Thread,130mm SS
008401944072436.5mm Cannulated Screw, 16mm Short Thread,128mm SS
008401944072366.5mm Cannulated Screw, 16mm Short Thread,126mm SS
008401944072296.5mm Cannulated Screw, 16mm Short Thread,125mm SS
008401944072126.5mm Cannulated Screw, 16mm Short Thread,124mm SS
008401944072056.5mm Cannulated Screw, 16mm Short Thread,122mm SS
008401944071996.5mm Cannulated Screw, 16mm Short Thread,120mm SS
008401944071826.5mm Cannulated Screw, 16mm Short Thread,118mm SS
008401944071756.5mm Cannulated Screw, 16mm Short Thread,116mm SS
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