AccessGUDID - DEVICE: Osia® 2 Sound Processor Tool Kit (09321502045124)

GUDID

Device Identifier (DI) Information

Brand Name: Osia® 2 Sound Processor Tool Kit
Version or Model: Osia 2 System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1343785
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502045124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64987	Hearing implant system sound processor activation kit	A collection of non-powered devices intended to be used by a healthcare professional in a clinical setting to assist with the activation/programming of a hearing implant system sound processor (not included). It typically includes a battery cover opener/closer, magnet inserter/remover, and temporary cover intended to protect the sound processor from environmental exposure during its connection to an external device (e.g., computer) for adjustment of settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFO	Active implantable bone conduction hearing system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191921	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b443735a-0b6c-468c-9dfe-4f263cb55cd5
Public Version Date: September 14, 2020
Public Version Number: 1
DI Record Publish Date: September 05, 2020