FDA UDI Not in Commercial Distribution 🇺🇸 United States

Miracle-Ear

DI: 04056839160657 · Model: HA ME 2275 S BLK · Ws Audiology Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Miracle-Ear
Primary DI
04056839160657
Version / Model
HA ME 2275 S BLK
Catalog Number
10934708
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-05-06
Public Version
6
Public Version Date
2023-02-08
Public Version Status
Update
Public Device Record Key
29747890-6833-4673-872d-86bd1d12d429
Distribution End Date
2020-11-30

Device Description

Miracle-Ear HA ME 2275 S BLK Hearing Aid

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ESD Hearing Aid, Air Conduction

GMDN Terms

Code Name
34671 Air-conduction hearing aid, behind-the-ear

Identifiers

Type ID
Primary 04056839160657

Customer Contacts

Phone
17325626600