GUDID EATO430165SINGLE9

K-wire with trocar point and thread, ø1.6, L 150

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: EATO430165SINGLE9
• NIH Device Record Key: 084f2a7b-6f5b-4bc4-ba99-cfec769f5281
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 430165SINGLE
• Company DUNS: 328420633
• Company Name: aap Implantate AG
• Device Count: 1
• DM Exempt: false
• 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
HIBCC	EATO430165SINGLE9 [Primary]

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

[EATO430165SINGLE9]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-16
• Device Publish Date: 2016-10-13

Devices Manufactured by aap Implantate AG

• 04042409047657 - NA: 2024-02-19 K-wire with trocar point, ø0.8, L 150
• 04042409047695 - NA: 2024-02-19 K-wire with trocar point, ø0.8, L 310
• 04042409047701 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 100
• 04042409047718 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 150
• 04042409047725 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 150
• 04042409047732 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 200
• 04042409047749 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 250
• 04042409047763 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 310