FDA UDI In Commercial Distribution 🇺🇸 United States

Two Striper

DI: B868C8400411 · Model: STAINBUSTER 2503 6-BUR PACK · ABRASIVE TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

Basic Information

Brand Name
Two Striper
Primary DI
B868C8400411
Version / Model
STAINBUSTER 2503 6-BUR PACK
Catalog Number
C840041
Company Name
ABRASIVE TECHNOLOGY, INC.
Labeler DUNS
054028295
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2021-05-25
Public Version
1
Public Version Date
2021-06-02
Public Version Status
New
Public Device Record Key
bff9e4f1-d39a-4834-9b5a-9ac901bf9633

Device Description

Abrasive Point

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EHL POINT, ABRASIVE

GMDN Terms

Code Name
58073 Polymeric dental bur

Identifiers

Type ID
Unit of Use B868C8400410
Primary B868C8400411