FDA UDI In Commercial Distribution 🇺🇸 United States

ApexPilot

DI: 00990010301351 · Model: AL2040 · Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
ApexPilot
Primary DI
00990010301351
Version / Model
AL2040
Catalog Number
ApexPilot
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
43c71c92-8f0e-4c00-814b-5157b4ae3fc8

Device Description

ApexPilot , Apex Locator, Rechargeable Battery

Device Characteristics

Single Use
Yes
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
No
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
No

Product Codes

Code Name
LQY Locator, Root Apex

GMDN Terms

Code Name
16355 Endodontic apex locator

Identifiers

Type ID
Primary 00990010301351

Premarket Submissions

Submission Number Supplement Number
K181087 000