Cochlear™ Nucleus® 8 Slimline™ Coil P1749616

GUDID 09321502053556

Brown, 6cm

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant coil

• Primary Device ID: 09321502053556
• NIH Device Record Key: 644e6c50-b78c-4da4-9ded-8790325ed8d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Nucleus® 8 Slimline™ Coil
• Version Model Number: P1749616
• Catalog Number: P1749616
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502053556 [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]

• 09321502054133: Silver, 25cm (10")
• 09321502054126: White, 25cm (10")
• 09321502054119: Sand, 25cm (10")
• 09321502054102: Grey, 25cm (10")
• 09321502054096: Brown, 25cm (10")
• 09321502054089: Black, 25cm (10")
• 09321502053952: Silver, 11cm (4")
• 09321502053945: White, 11cm (4")
• 09321502053938: Sand, 11cm (4")
• 09321502053921: Grey, 11cm (4")
• 09321502053914: Brown, 11cm (4")
• 09321502053907: Black, 11cm (4")
• 09321502053778: Silver, 8cm (3")
• 09321502053761: White, 8cm (3")
• 09321502053754: Sand, 8cm (3")
• 09321502053747: Grey, 8cm (3")
• 09321502053730: Brown, 8cm (3")
• 09321502053723: Black, 8cm (3")
• 09321502053594: Silver, 6cm
• 09321502053587: White, 6cm
• 09321502053570: Sand, 6cm
• 09321502053563: Grey, 6cm
• 09321502053556: Brown, 6cm
• 09321502053549: Black, 6cm