FDA UDI In Commercial Distribution 🇺🇸 United States

freeprint shell beige 1000 g

DI: EDET037471 · Model: 03747 · DETAX GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
freeprint shell beige 1000 g
Primary DI
EDET037471
Version / Model
03747
Company Name
DETAX GmbH
Labeler DUNS
343947949
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-25
Public Version
2
Public Version Date
2022-11-08
Public Version Status
Update
Public Device Record Key
4c5c8222-c167-4285-bbc0-b24ebb4db2b5

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
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
41228 Earmould, custom-made

Identifiers

Type ID
Primary EDET037471