FDA UDI In Commercial Distribution 🇺🇸 United States

Interacoustics

DI: 05711117122053 · Model: Pediatric Eartip Kit · Interacoustics A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Interacoustics
Primary DI
05711117122053
Version / Model
Pediatric Eartip Kit
Company Name
Interacoustics A/S
Labeler DUNS
306308354
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-12-16
Public Version
1
Public Version Date
2024-12-24
Public Version Status
New
Public Device Record Key
8d797cf1-acf5-4e7e-b31c-e73f0c31ff13

Device Description

Audiometric ear tip kit

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ETT Cushion, Earphone (For Audiometric Testing)

GMDN Terms

Code Name
66677 Vestibulo-auditory analysis system support kit¿

Identifiers

Type ID
Primary 05711117122053