GDW-2060-0001

GUDID EATOGDW20600001

K-wire with trocar point, ø1.4, L 150 (Single)

aap Implantate AG

Orthopaedic bone wire

• Primary Device ID: EATOGDW20600001
• NIH Device Record Key: cf3004f9-b3f9-43ff-a446-70ff9992ca31
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GDW-2060-0001
• Catalog Number: GDW-2060-0001
• 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	EATOGDW20600001 [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

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

[EATOGDW20600001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-06
• Device Publish Date: 2019-11-28

Devices Manufactured by aap Implantate AG

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• 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