FDA UDI In Commercial Distribution 🇺🇸 United States

Sanibel Supply A/S

DI: 05711117217254 · Model: Sample bag - AuDX and OAE foam tips · Interacoustics A/S
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sanibel Supply A/S
Primary DI
05711117217254
Version / Model
Sample bag - AuDX and OAE foam tips
Catalog Number
8515508
Company Name
Interacoustics A/S
Labeler DUNS
306308354
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-12-03
Public Version
1
Public Version Date
2024-12-11
Public Version Status
New
Public Device Record Key
17a0435f-e0b4-4b4c-aafe-df5ad63a82a2

Device Description

Audiometric ear tip kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
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

GMDN Terms

Code Name
66677 Vestibulo-auditory analysis system support kit¿

Identifiers

Type ID
Primary 05711117217254