FDA UDI In Commercial Distribution 🇺🇸 United States

ApexPilot

DI: 00990010301337 · Model: AL2020 · Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ApexPilot
Primary DI
00990010301337
Version / Model
AL2020
Catalog Number
ApexPilot All-In-One
Company Name
Beyes Dental Canada Inc
Labeler DUNS
244261462
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-05-11
Public Version
1
Public Version Date
2023-05-19
Public Version Status
New
Public Device Record Key
83c4bc2a-b640-4eaa-b6a7-a29b5c301665

Device Description

ApexPilot All-In-One, Cordless Endodontic Handpiece, Built-in Apex Locator

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
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
EKR Plugger, Root Canal, Endodontic

GMDN Terms

Code Name
16355 Endodontic apex locator

Identifiers

Type ID
Primary 00990010301337