FDA UDI In Commercial Distribution 🇺🇸 United States

American Eagle Instruments

DI: 00841013102011 · Model: AEBH7 · AMERICAN EAGLE INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
American Eagle Instruments
Primary DI
00841013102011
Version / Model
AEBH7
Catalog Number
AEBH7
Company Name
AMERICAN EAGLE INSTRUMENTS, INC.
Labeler DUNS
790776850
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-05-23
Public Version
4
Public Version Date
2022-10-05
Public Version Status
Update
Public Device Record Key
1b1481f6-0cb5-4c03-b93b-9c643ac26d3c

Device Description

BURNISHER HOLLENBACK 7

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EKK SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

GMDN Terms

Code Name
64078 Manual dental burnisher, reusable

Identifiers

Type ID
Primary 00841013102011