Cochlear™ Headband P783385

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number09321502034715 UDI-DI	Date5 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP970051	Date25 Jun 1998Decided	StatusActive

Official records

AccessGUDID record UDI-DI 09321502034715
FDA PMA database PMA number P970051

Recalls

3 recalls · FDA

- Terminated Z-2155-2015 FDA Class II initiated 5 Jun 2015
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
- Terminated Z-0003-2012 FDA Unclassified (pre-2012) initiated 16 Sep 2011
Cochlear implant may shut down and cease to function.
- Terminated Z-0119-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009
Cochlear implant device component was mis-labeled.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Cochlear™ Headband
Generic name: Cochlear implant/auditory brainstem implant sound processor earhook
Model / Ref / Catalog: P783385

Primary DI / UDI-DI: 09321502034715
PMA number: P970051
FDA product code: MCM
GMDN term: Cochlear implant/auditory brainstem implant sound processor earhook

Device class: Class III
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

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Properties

Prescription use
Manufacturing date

Other properties (13)

Supplied sterile: No
Sterilise before use: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Lot / batch number: No
Serial number: No
Expiration date: No