Impression coping squared

GUDID 09321502063425

to be used as a temporary abutment template that shall be attached to an abutment to get the exact reference point of the actual abutment when making an impression of the prosthesis site

Cochlear Bone Anchored Solutions AB

General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: 09321502063425
• NIH Device Record Key: 3c000284-462d-49a3-a3ac-949ef38d9f05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impression coping squared
• Version Model Number: 90379
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502063425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945154

FDA Product Code

• FZE: PROSTHESIS, NOSE, INTERNAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-21
• Device Publish Date: 2023-08-11

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• 09321502040198 - Baha: 2023-11-29 BP110 Power battery doors Iris Purple
• 09321502040204 - Baha: 2023-11-29 BP110 Power battery doors Ruby Red
• 09321502040259 - Baha: 2023-11-29 Inner Case BP110 (Spare part)
• 09321502012812 - Baha: 2023-11-21 Audio adapter Headworn devices
• 09321502012829 - Baha: 2023-11-21 Telecoil black