GUDID EATO430490SINGLE9

Washer, I-ø8.5, O-ø13.0

aap Implantate AG

Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

• Primary Device ID: EATO430490SINGLE9
• NIH Device Record Key: c8777adb-2977-47ac-833a-dd2aebe18a39
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 430490SINGLE
• 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	EATO430490SINGLE9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990776

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

Moist Heat or Steam Sterilization

[EATO430490SINGLE9]

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

• 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