Cochlear™ Nucleus® 8 Slimline™ Coil (5(I)) P1749645

GUDID 09321502053648

White, 6cm (2 1/2")

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant coil

• Primary Device ID: 09321502053648
• NIH Device Record Key: afe69f6e-a915-4d1b-b58e-4effa11bb83b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Nucleus® 8 Slimline™ Coil (5(I))
• Version Model Number: P1749645
• Catalog Number: P1749645
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Length: 6 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502053648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051

FDA Product Code

• MCM: Implant, cochlear

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: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Cochlear™ Nucleus® 8 Slimline™ Coil (5(I))]

• 09321502054256: Silver, 25cm (10")
• 09321502054249: White, 25cm (10")
• 09321502054232: Sand, 25cm (10")
• 09321502054225: Grey, 25cm (10")
• 09321502054218: Brown, 25cm (10")
• 09321502054201: Black, 25cm (10")
• 09321502054072: Silver, 11cm (4")
• 09321502054065: White, 11cm (4")
• 09321502054058: Sand, 11cm (4")
• 09321502054041: Grey, 11cm (4")
• 09321502054034: Brown, 11cm (4")
• 09321502054027: Black, 11cm (4")
• 09321502053891: Silver, 8cm (3")
• 09321502053884: White, 8cm (3")
• 09321502053877: Sand, 8cm (3")
• 09321502053860: Grey, 8cm (3")
• 09321502053853: Brown, 8cm (3")
• 09321502053846: Black, 8cm (3")
• 09321502053655: Silver, 6cm (2 1/2")
• 09321502053648: White, 6cm (2 1/2")
• 09321502053631: Sand, 6cm (2 1/2")
• 09321502053624: Grey, 6cm (2 1/2")
• 09321502053617: Brown, 6cm (2 1/2")
• 09321502053600: Black, 6cm (2 1/2")