NK 2016-15-2

GUDID 04042409117442

K-wire with 2 trocar points, ø1.6, L 150

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: 04042409117442
• NIH Device Record Key: 36d04b98-5a55-4dc5-bca4-c7f517773047
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NK 2016-15-2
• Catalog Number: NK 2016-15-2
• 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	04042409117442 [Primary]
GS1	04042409391453 [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

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

Moist Heat or Steam Sterilization

[04042409117442]

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

• 04042409042102 - NA: 2025-03-06 Direct measuring device for K-Wire, L 250
• 04042409451348 - NA: 2025-03-06 K-Wire with trocar point and thread, Ø2.4, L 250
• 04042409452000 - NA: 2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling
• 04042409452024 - NA: 2025-03-06 Drill, Ø2.0, cannulated, I-Ø1.1, L 130, quick coupling, Single Use
• 04042409452062 - NA: 2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling
• 04042409452086 - NA: 2025-03-06 Drill, Ø2.5, cannulated, I-Ø1.3, L 145, quick coupling, Single Use
• 04042409452123 - NA: 2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling
• 04042409452147 - NA: 2025-03-06 Drill, Ø3.7, cannulated, I-Ø1.75, L 215, quick coupling, Single Use