ORTHOMED OM 71-0109R

GUDID B8037101093

K-WIRE DBL.TROCAR PT. 5" .062"1.6MM

ORTHO-MED, INC.

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire
Primary Device IDB8037101093
NIH Device Record Keye5ad0177-0858-4917-9cce-13b03acf2dd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOMED
Version Model NumberOM 71-0109R
Catalog NumberOM 71-0109R
Company DUNS086618626
Company NameORTHO-MED, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone503-234-9691
EmailSUPPORT@ORTHOMEDINC.COM
Phone503-234-9691
EmailSUPPORT@ORTHOMEDINC.COM
Phone503-234-9691
EmailSUPPORT@ORTHOMEDINC.COM

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB8037101093 [Package]
Contains: B803710109R0
Package: TUBE [6 Units]
In Commercial Distribution
HIBCCB8037101093 [Package]
Contains: B803710109R0
Package: TUBE [6 Units]
In Commercial Distribution
HIBCCB8037101093 [Package]
Contains: B803710109R0
Package: TUBE [6 Units]
In Commercial Distribution
HIBCCB803710109R0 [Primary]
HIBCCB803710109R0 [Primary]
HIBCCB803710109R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth
HTYPin, Fixation, Smooth
HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B8037101093]

Moist Heat or Steam Sterilization


[B8037101093]

Moist Heat or Steam Sterilization


[B8037101093]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [ORTHOMED]

B803710100R0K-WIRE DBL TROCAR PT. 4" X .028" (.7MM)
B8037101753K-WIRE S.TROCAR 5" .062"1.6MM
B8037101743K-WIRE S.TROCAR PT.5" .054"1.4MM
B8037101723K-WIRE S.TROCAR PT.5".045"1.1MM
B8037101713K-WIRE S.TROCAR PT.5" .035".9MM
B8037101343K-WIRE S.TROCAR 4" .062" 1.6MM
B8037101333K-WIRE S.TROCAR 4" .054" 1.4MM
B8037101323K-WIRE S.TROCAR 4" .045" 1.1MM
B8037101313K-WIRE S.TROCAR 4" .035" .9MM
B8037101233K-WIRE D.TROCAR PT.12".062" 1.6MM
B8037101143K-WIRE DBL.TROCAR PT. 9" .054"1.4MM
B8037101133K-WIRE DBL.TROCAR PT. 9" .062"1.6MM
B8037101123K-WIRE DBL.TROCAR PT. 9" .045"1.1MM
B8037101113K-WIRE DBL.TROCAR PT. 9" .035"0.9MM
B8037101103K-WIRE DBL.TROCAR PT. 9" .028"0.7MM
B8037101093K-WIRE DBL.TROCAR PT. 5" .062"1.6MM
B8037101083K-WIRE DBL.TROCAR PT. 5" .054"1.4MM
B8037101073K-WIRE DBL.TROCAR PT. 5" .045"1.1MM
B8037101053K-WIRE DBL.TROCAR PT. 5" .028".7MM
B8037101043K-WIRE DBL.TROCAR PT. 4" .054"1.4MM
B8037101033K-WIRE DBL.TROCAR PT. 4" .062"1.6MM
B8037101023K-WIRE DBL.TROCAR PT. 4" X .045" (1.1MM)
B803710101R0K-WIRE DBL TROCAR PT. 4" x .035" (.9MM)
B8037100253K-WIRE DBL.TROCAR PT.6" .062" 1.6MM
B8037100243K-WIRE DBL.TROCAR PT.6" .054" 1.4MM
B8037100233K-WIRE DBL.TROCAR PT.6" .045" 1.1MM
B8037100223K-WIRE DBL.TROCAR PT.6" .035" 0.9MM
B8037100213K-WIRE DBL.TROCAR PT.6" .028" 0.7MM

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