SU 0448-00-2

GUDID 04042409360176

Washer, I-ø4.4, O-ø8.0, Titanium

aap Implantate AG

Implantable bone washer

• Primary Device ID: 04042409360176
• NIH Device Record Key: 1ddcf3d6-54d1-4554-b664-e89016093a40
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SU 0448-00-2
• Catalog Number: SU 0448-00-2
• Company DUNS: 328420633
• Company Name: aap Implantate AG
• Device Count: 1
• 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	04042409360176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161703

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

[04042409360176]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2016-11-11

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