GUDID EATO4302909

Washer, I-ø4.5, O-ø8.0

aap Implantate AG

Orthopaedic bone washer, non-sterile

• Primary Device ID: EATO4302909
• NIH Device Record Key: 5cede058-479d-43c1-ae96-58224ba33c68
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 430290
• Company DUNS: 328420633
• Company Name: aap Implantate AG
• Device Count: 5
• 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	EATO4302909 [Primary]
HIBCC	EATO430290SINGLE9 [Unit of Use]

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

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

[EATO4302909]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-15

Devices Manufactured by aap Implantate AG

• 04042409220159 - LOQTEQ®: 2025-06-03 Trocar, LOQTEQ DF 4.5
• 04042409453663 - CHBS: 2025-05-29 Tray for instruments CHBS 2.5/3.0, empty
• 04042409453724 - CHBS: 2025-05-29 Screw rack CHBS 2.5/3.0, empty
• 04042409453823 - CHBS: 2025-05-29 Tray for instruments CHBS 3.5/4.0, empty
• 04042409453861 - CHBS: 2025-05-29 Screw rack CHBS 3.5/4.0, empty
• 04042409453922 - CHBS: 2025-05-29 Tray for instruments CHBS 4.5/5.0, empty
• 04042409453984 - CHBS: 2025-05-29 Tray for implants CHBS 4.5/5.0, empty
• 04042409454042 - CHBS: 2025-05-29 Screw rack CHBS 4.5/5.0, empty