ORTHOMED OM 71-0459R

GUDID B8037104593

STEIN.PIN DBL.TROCAR 9" 1/8" 3.2MM

ORTHO-MED, INC.

Orthopaedic bone wire

• Primary Device ID: B8037104593
• NIH Device Record Key: 5e68016e-8e7c-43d9-ba96-40552d03ec00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOMED
• Version Model Number: OM 71-0459R
• Catalog Number: OM 71-0459R
• Company DUNS: 086618626
• Company Name: ORTHO-MED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM
• Phone: 503-234-9691
• Email: SUPPORT@ORTHOMEDINC.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B8037104593 [Package]; Contains: B803710459R0; Package: TUBE [6 Units]; In Commercial Distribution
HIBCC	B803710459R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102845

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

[B8037104593]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-26
• Device Publish Date: 2020-05-18

On-Brand Devices [ORTHOMED]

• B803710100R0: K-WIRE DBL TROCAR PT. 4" X .028" (.7MM)
• B8037101753: K-WIRE S.TROCAR 5" .062"1.6MM
• B8037101743: K-WIRE S.TROCAR PT.5" .054"1.4MM
• B8037101723: K-WIRE S.TROCAR PT.5".045"1.1MM
• B8037101713: K-WIRE S.TROCAR PT.5" .035".9MM
• B8037101343: K-WIRE S.TROCAR 4" .062" 1.6MM
• B8037101333: K-WIRE S.TROCAR 4" .054" 1.4MM
• B8037101323: K-WIRE S.TROCAR 4" .045" 1.1MM
• B8037101313: K-WIRE S.TROCAR 4" .035" .9MM
• B8037101233: K-WIRE D.TROCAR PT.12".062" 1.6MM
• B8037101143: K-WIRE DBL.TROCAR PT. 9" .054"1.4MM
• B8037101133: K-WIRE DBL.TROCAR PT. 9" .062"1.6MM
• B8037101123: K-WIRE DBL.TROCAR PT. 9" .045"1.1MM
• B8037101113: K-WIRE DBL.TROCAR PT. 9" .035"0.9MM
• B8037101103: K-WIRE DBL.TROCAR PT. 9" .028"0.7MM
• B8037101093: K-WIRE DBL.TROCAR PT. 5" .062"1.6MM
• B8037101083: K-WIRE DBL.TROCAR PT. 5" .054"1.4MM
• B8037101073: K-WIRE DBL.TROCAR PT. 5" .045"1.1MM
• B8037101053: K-WIRE DBL.TROCAR PT. 5" .028".7MM
• B8037101043: K-WIRE DBL.TROCAR PT. 4" .054"1.4MM
• B8037101033: K-WIRE DBL.TROCAR PT. 4" .062"1.6MM
• B8037101023: K-WIRE DBL.TROCAR PT. 4" X .045" (1.1MM)
• B803710101R0: K-WIRE DBL TROCAR PT. 4" x .035" (.9MM)
• B8037100253: K-WIRE DBL.TROCAR PT.6" .062" 1.6MM
• B8037100243: K-WIRE DBL.TROCAR PT.6" .054" 1.4MM
• B8037100233: K-WIRE DBL.TROCAR PT.6" .045" 1.1MM
• B8037100223: K-WIRE DBL.TROCAR PT.6" .035" 0.9MM
• B8037100213: K-WIRE DBL.TROCAR PT.6" .028" 0.7MM
• B8037102513: K-WIRE S.DIAMOND RD.12".035"0.9MM
• B8037102503: K-WIRE S.DIAMOND RD.12".028"0.7MM
• B8037102443: K-WIRE S.DIAMOND RD.9" .054"1.4MM
• B8037102433: K-WIRE S.DIAMOND RD.9" .062"1.6MM
• B8037102423: K-WIRE S.DIAMOND RD.9" .045"1.1MM
• B8037102413: K-WIRE S.DIAMOND RD.9" .035"0.9MM
• B8037102403: K-WIRE S.DIAMOND RD.9" .028"0.7MM
• B8037102343: K-WIRE S.DIAMOND RD.4" .062"1.6MM
• B8037102333: K-WIRE S.DIAMOND RD.4" .054"1.4MM
• B8037102323: K-WIRE S.DIAMOND RD.4" .045"1.1MM
• B8037102313: K-WIRE S.DIAMOND RD.4" .035"0.9MM
• B8037102303: K-WIRE S.DIAMOND RD.4" .028"0.7MM
• B8037102143: K-WIRE DBL.DIAMOND 9" .054" 1.4MM
• B8037102133: K-WIRE DBL.DIAMOND 9" .062" 1.6MM
• B8037102123: K-WIRE DBL.DIAMOND 9" .045" 1.1MM
• B8037102113: K-WIRE DBL.DIAMOND 9" .035" 0.9MM
• B8037102103: K-WIRE DBL.DIAMOND 9" .028" 0.7MM
• B8037102093: K-WIRE DBL.DIAMOND 5" .062" 1.6MM
• B8037102083: K-WIRE DBL.DIAMOND 5" .054" 1.4MM
• B8037102073: K-WIRE DBL.DIAMOND 5" .045" 1.1MM
• B8037102063: K-WIRE DBL.DIAMOND 5" .035" 0.9MM
• B8037102053: K-WIRE DBL.DIAMOND 5" .028" 0.7MM