FDA UDI In Commercial Distribution 🇺🇸 United States

Two Striper

DI: B868C8010021 · Model: CARBOPOST INTROKIT-20 ASSTD W/DRILLS · ABRASIVE TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
Two Striper
Primary DI
B868C8010021
Version / Model
CARBOPOST INTROKIT-20 ASSTD W/DRILLS
Catalog Number
C801002
Company Name
ABRASIVE TECHNOLOGY, INC.
Labeler DUNS
054028295
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
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
1b935d28-c91b-4c12-8f5e-646ac0e5b88f

Device Description

Dental Root Canal Post

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
ELR POST, ROOT CANAL

GMDN Terms

Code Name
38609 Root canal post, preformed

Identifiers

Type ID
Unit of Use B868C8010020
Primary B868C8010021