FDA UDI Not in Commercial Distribution 🇺🇸 United States

egger

DI: EGOL307010 · Model: LP/W lacquer, soft, 100 ml · Egger Otoplastik + Labortechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
egger
Primary DI
EGOL307010
Version / Model
LP/W lacquer, soft, 100 ml
Company Name
Egger Otoplastik + Labortechnik GmbH
Labeler DUNS
328465042
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-31
Public Version
2
Public Version Date
2024-09-27
Public Version Status
Update
Public Device Record Key
e5e13637-41f5-4bbf-b0f1-1ba6c7e6f559
Distribution End Date
2024-05-26

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

GMDN Terms

Code Name
41228 Earmould, custom-made

Identifiers

Type ID
Primary EGOL307010