NK 1012-15-2

GUDID 04042409048678

K-wire with thread and trocar point, ø1.2, L 150

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: 04042409048678
• NIH Device Record Key: eed73c37-ba44-4605-be3d-31fe7b2a3e9d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NK 1012-15-2
• Catalog Number: NK 1012-15-2
• 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	04042409048678 [Primary]
GS1	04042409391170 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131459

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

Moist Heat or Steam Sterilization

[04042409048678]

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

• 04042409240447 - NA: 2025-01-16 Drill CS 4.0, ø2.5, L 130, quick coupling, single use
• 04042409240454 - NA: 2025-01-16 Drill CS 4.5, ø3.0, L 130, quick coupling, single use
• 04042409240461 - NA: 2025-01-16 Drill CS 4.0, ø4.0, L 130, quick coupling, single use
• 04042409240478 - NA: 2025-01-16 Drill CS 4.5, ø4.5, L 130, quick coupling, single use
• 04042409240485 - NA: 2025-01-16 Cannulated drill CS 6.5, ø4.4, L 220, Hudson, single use
• 04042409240508 - NA: 2025-01-16 Countersink CS 6.5/7.5, Hudson
• 04042409240713 - NA: 2025-01-16 Parallel guide for K-wires, CS 6.5/7.5
• 04042409240744 - NA: 2025-01-16 Screwdriver cannulated CS 6.5/7.5, hex, ø5.0, Hudson