SC 4000-32-2

GUDID 04042409074486

Cannulated screw 4.0, full thread, L 32

aap Implantate AG

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04042409074486
• NIH Device Record Key: 027fba8a-d95e-41cd-8633-c48ea8bfb594
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SC 4000-32-2
• Catalog Number: SC 4000-32-2
• 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	04042409074486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111316

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[04042409074486]

Moist Heat or Steam Sterilization

[04042409074486]

Moist Heat or Steam Sterilization

[04042409074486]

Moist Heat or Steam Sterilization

[04042409074486]

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

• 04042409037993 - NA: 2024-07-15 Cleaning wire ø1.2, CS 2.7-4.0
• 04042409038006 - NA: 2024-07-15 Cleaning wire ø1.6, CS 4.5
• 04042409038013 - NA: 2024-07-15 Cleaning wire ø3.0, CS 7.5
• 04042409097263 - NA: 2024-07-15 Cleaning wire ø2.0, CS 5.8
• 04042409097324 - NA: 2024-07-15 Cleaning wire ø2.5, CS 6.5
• 04042409196409 - NA: 2024-07-15 Cleaning wire ø0.8, CS 2.0/2.7
• 04042409197338 - NA: 2024-07-15 Drill CS 4.0, ø2.5, L 130, I-ø1.4, single use
• 04042409197369 - NA: 2024-07-15 Drill CS 3.5, ø2.7, L 120, I-ø1.4, single use