NK 2008-15

GUDID 04042409049279

K-wire with 2 trocar points, ø0.8, L 150

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: 04042409049279
• NIH Device Record Key: 3177eb3b-18c4-4498-b5db-b6940d217f14
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NK 2008-15
• Catalog Number: NK 2008-15
• Company DUNS: 328420633
• Company Name: aap Implantate AG
• Device Count: 10
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04042409049279 [Primary]
GS1	04042409391385 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131459

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

[04042409049279]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2016-08-18

Devices Manufactured by aap Implantate AG

• 04042409220159 - LOQTEQ®: 2025-06-03 Trocar, LOQTEQ DF 4.5
• 04042409453663 - CHBS: 2025-05-29 Tray for instruments CHBS 2.5/3.0, empty
• 04042409453724 - CHBS: 2025-05-29 Screw rack CHBS 2.5/3.0, empty
• 04042409453823 - CHBS: 2025-05-29 Tray for instruments CHBS 3.5/4.0, empty
• 04042409453861 - CHBS: 2025-05-29 Screw rack CHBS 3.5/4.0, empty
• 04042409453922 - CHBS: 2025-05-29 Tray for instruments CHBS 4.5/5.0, empty
• 04042409453984 - CHBS: 2025-05-29 Tray for implants CHBS 4.5/5.0, empty
• 04042409454042 - CHBS: 2025-05-29 Screw rack CHBS 4.5/5.0, empty