FDA UDI In Commercial Distribution 🇺🇸 United States

Sanibel Supply A/S

DI: 05711117105414 · Model: Cable for TM ECochG electrode · Interacoustics A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Sanibel Supply A/S
Primary DI
05711117105414
Version / Model
Cable for TM ECochG electrode
Catalog Number
8500650 (1 pcs)
Company Name
Interacoustics A/S
Labeler DUNS
306308354
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-11-29
Public Version
2
Public Version Date
2023-12-18
Public Version Status
Update
Public Device Record Key
8ae14755-f154-4564-ae4b-deae3ba4f967

Device Description

Electrode cable for TM Electrode

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
IKD Cable, Electrode

GMDN Terms

Code Name
35750 Analytical non-scalp cutaneous lead

Identifiers

Type ID
Primary 05711117105414