0211130410

GUDID H67902111304100

1.25MM KIRSCHNER WIRE WITH TROCAR TIP/80MM

SYNTHES (U.S.A.) LP

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire 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 ID: H67902111304100
• NIH Device Record Key: b9f48a30-d542-40b2-b49c-6228bc02794e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 02.111.304.10
• Catalog Number: 0211130410
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 10
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	20886982031645 [Primary]
GS1	80886982031647 [Unit of Use]
HIBCC	H67902111304100 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103243

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

[H67902111304100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-21

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• H679022221140 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM
• H679022221160 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
• H679022221180 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
• H679022221200 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
• H679022221240 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM