FDA UDI In Commercial Distribution 🇺🇸 United States

Oticon

DI: 05707131332875 · Model: 182600 · Oticon A/S
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Oticon
Primary DI
05707131332875
Version / Model
182600
Company Name
Oticon A/S
Labeler DUNS
305839946
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-20
Public Version
2
Public Version Date
2020-10-06
Public Version Status
Update
Public Device Record Key
35a92895-c4e5-4e32-967a-468048518a02

Device Description

OPN 2, KIT 312 NFM PB L C001

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
MR Unsafe
Direct Marking Exempt
Yes
PM Exempt
No
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
KLW Masker, tinnitus
OSM Hearing aid, air conduction with wireless technology

GMDN Terms

Code Name
34672 Air-conduction hearing aid, in-the-ear

Identifiers

Type ID
Primary 05707131332875

Customer Contacts

Phone
+4539177100