Simpex Kirschner Wire KD-028-9

GUDID B068KD02891

Smooth K-Wire, Double Diamond Tip; .028" DIA x 9" LG; Material: 316L Stainless Steel

SIMPEX MEDICAL, INC.

Orthopaedic bone wire

• Primary Device ID: B068KD02891
• NIH Device Record Key: 5d75e5f0-dc8e-489a-b12a-2843f3722ebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpex Kirschner Wire
• Version Model Number: KD-028-9
• Catalog Number: KD-028-9
• Company DUNS: 932637023
• Company Name: SIMPEX MEDICAL, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-851-9753
• Email: info@simpexmedical.com
• Phone: 800-851-9753
• Email: info@simpexmedical.com

Device Dimensions

• Length: 229 Millimeter
• Outer Diameter: 0.7 Millimeter
• Length: 229 Millimeter
• Outer Diameter: 0.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B068KD02891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911505

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[B068KD02891]

Moist Heat or Steam Sterilization

[B068KD02891]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-23

On-Brand Devices [Simpex Kirschner Wire]

• B068TK0629S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK06291: Smooth K-Wire, Double Trocar Tip; .062" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK0626S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK06261: Smooth K-Wire, Double Trocar Tip; .062" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK0625S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK06251: Smooth K-Wire, Double Trocar Tip; .062" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK0624S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK06241: Smooth K-Wire, Double Trocar Tip; .062" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK062149S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 5.8" LG; Material: 316L Stainless Steel
• B068TK06212S1: Smooth K-Wire, Single Trocar Tip; .062" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK062121: Smooth K-Wire, Double Trocar Tip; .062" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK0549S1: Smooth K-Wire, Single Trocar Tip; .054" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK05491: Smooth K-Wire, Double Trocar Tip; .054" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK0546S1: Smooth K-Wire, Single Trocar Tip; .054" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK05461: Smooth K-Wire, Double Trocar Tip; .054" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK0545S1: Smooth K-Wire, Single Trocar Tip; .054" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK05451: Smooth K-Wire, Double Trocar Tip; .054" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK0544S1: Smooth K-Wire, Single Trocar Tip; .054" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK05441: Smooth K-Wire, Double Trocar Tip; .054" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK05412S1: Smooth K-Wire, Single Trocar Tip; .054" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK054121: Smooth K-Wire, Double Trocar Tip; .054" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK0459S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK04591: Smooth K-Wire, Double Trocar Tip; .045" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK0456S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK04561: Smooth K-Wire, Double Trocar Tip; .045" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK0455S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK04551: Smooth K-Wire, Double Trocar Tip; .045" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK0454S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK04541: Smooth K-Wire, Double Trocar Tip; .045" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK045149S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 5.8" LG; Material: 316L Stainless Steel
• B068TK04512S1: Smooth K-Wire, Single Trocar Tip; .045" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK045121: Smooth K-Wire, Double Trocar Tip; .045" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK0359S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK03591: Smooth K-Wire, Double Trocar Tip; .035" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK0356S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK03561: Smooth K-Wire, Double Trocar Tip; .035" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK0355S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK03551: Smooth K-Wire, Double Trocar Tip; .035" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK0354S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK03541: Smooth K-Wire, Double Trocar Tip; .035" DIA x 4" LG; Material: 316L Stainless Steel
• B068TK035149S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 5.8" LG; Material: 316L Stainless Steel
• B068TK03512S1: Smooth K-Wire, Single Trocar Tip; .035" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK035121: Smooth K-Wire, Double Trocar Tip; .035" DIA x 12" LG; Material: 316L Stainless Steel
• B068TK0289S1: Smooth K-Wire, Single Trocar Tip; .028" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK02891: Smooth K-Wire, Double Trocar Tip; .028" DIA x 9" LG; Material: 316L Stainless Steel
• B068TK0286S1: Smooth K-Wire, Single Trocar Tip; .028" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK02861: Smooth K-Wire, Double Trocar Tip; .028" DIA x 6" LG; Material: 316L Stainless Steel
• B068TK0285S1: Smooth K-Wire, Single Trocar Tip; .028" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK02851: Smooth K-Wire, Double Trocar Tip; .028" DIA x 5" LG; Material: 316L Stainless Steel
• B068TK0284S1: Smooth K-Wire, Single Trocar Tip; .028" DIA x 4" LG; Material: 316L Stainless Steel