NK 0010-28

GUDID 04042409180804

K-wire with trocar point, ø1.0, L 280

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: 04042409180804
• NIH Device Record Key: 1871c2f3-1251-4a9c-8a97-7f26b13d5055
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NK 0010-28
• Catalog Number: NK 0010-28
• 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	04042409180804 [Primary]
GS1	04042409390593 [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

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

Moist Heat or Steam Sterilization

[04042409180804]

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

• 04042409449840 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 75, TL 15 short, Titanium
• 04042409449864 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 80, TL 20 short, Titanium
• 04042409449888 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 85, TL 20 short, Titanium
• 04042409449901 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 90, TL 20 short, Titanium
• 04042409449925 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 95, TL 20 short, Titanium
• 04042409449949 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 100, TL 20 short, Titanium
• 04042409449963 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 105, TL 20 short, Titanium
• 04042409449987 - NA: 2024-10-07 Cannulated Headless Bone Screw 6.5, L 110, TL 20 short, Titanium