AccessGUDID - DEVICE: Phonak Brand (07613389393118)

GUDID

Device Identifier (DI) Information

Brand Name: Phonak Brand
Version or Model: 050-0771-0090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 050-0771-0090
Company Name: Sonova AG

Primary DI Number: 07613389393118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480662550 *Terms of Use

Device Description: Phonak Audéo P90-R

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
Over the Counter (OTC):	No
Kit:	No
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?
47170	Superficial skin exfoliant, home-use	A substance applied to the surface of the skin for the chemical removal of the superficial cells of the epidermis (desquamation) typically to remove wrinkles, acne, acne scars, pigmentations, and other skin pathologies for dermatological and/or aesthetic purposes; it is not intended to treat corns or calluses. It typically includes as active ingredients acids (e.g., salicylic, glycolic, citric, malic, alpha hydroxy, beta hydroxy) and/or enzymes (e.g., fruit). It is available [non-prescription] over-the-counter (OTC) as a gel or liquid solution for use in the home and healthcare facility. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing aid, air conduction with wireless technology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c87e8e1-2581-4185-91dc-4a9e907ca4d0
Public Version Date: November 06, 2020
Public Version Number: 2
DI Record Publish Date: July 22, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41589280101
Email: info@sonova.com

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