FDA UDI Not in Commercial Distribution 🇺🇸 United States

aquaplus red 50 ml

DI: EDET028491 · Model: 02849 · DETAX GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
aquaplus red 50 ml
Primary DI
EDET028491
Version / Model
02849
Company Name
DETAX GmbH
Labeler DUNS
343947949
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-29
Public Version
2
Public Version Date
2023-07-14
Public Version Status
Update
Public Device Record Key
c05a71b3-1842-49e8-a8cf-1c546ec82a50
Distribution End Date
2023-06-29

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
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ESD Hearing Aid, Air-Conduction, Prescription

GMDN Terms

Code Name
44974 Earmould impression material

Identifiers

Type ID
Primary EDET028491