FDA UDI In Commercial Distribution 🇺🇸 United States

Dental City

DI: D77139PEA1 · Model: 39-PEA · ICP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

Basic Information

Brand Name
Dental City
Primary DI
D77139PEA1
Version / Model
39-PEA
Company Name
ICP, INC.
Labeler DUNS
808371371
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2021-07-19
Public Version
1
Public Version Date
2021-07-27
Public Version Status
New
Public Device Record Key
db13408e-f872-44e8-9ff7-86184a65d06b

Device Description

Peeso Reamers Assorted 32mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
EKP Reamer, Pulp Canal, Endodontic

GMDN Terms

Code Name
63720 Manual endodontic file/rasp, single-use

Identifiers

Type ID
Unit of Use D77139PEA0
Primary D77139PEA1