FDA UDI In Commercial Distribution 🇺🇸 United States

DENTALAIRE

DI: 00990010306332 · Model: DA400LEDMH · Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
DENTALAIRE
Primary DI
00990010306332
Version / Model
DA400LEDMH
Catalog Number
Dentalaire LED kit
Company Name
Beyes Dental Canada Inc
Labeler DUNS
244261462
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-12-27
Public Version
1
Public Version Date
2024-01-04
Public Version Status
New
Public Device Record Key
169a133a-b22f-41ea-b4f4-1b1312922ff4

Device Description

DA400LEDMH, LED High Speed Handpiece Retrofit any air powered dental station with LED lighting

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
EFB Handpiece, Air-Powered, Dental

GMDN Terms

Code Name
45121 Pneumatic dental handpiece coupler

Identifiers

Type ID
Primary 00990010306332