FDA UDI In Commercial Distribution 🇺🇸 United States

American Eagle Instruments

DI: 00841013103032 · Model: AECAIPCLTNZ · AMERICAN EAGLE INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
American Eagle Instruments
Primary DI
00841013103032
Version / Model
AECAIPCLTNZ
Catalog Number
AECAIPCLTNZ
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
56c07a31-7d78-40d1-9c54-188d4aebe324

Device Description

CARVER IPC LONG TN (3/8 SS)

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
EKH CARVER, DENTAL AMALGAM, OPERATIVE

GMDN Terms

Code Name
35793 Dental restoration carver, amalgam, reusable

Identifiers

Type ID
Primary 00841013103032