FDA UDI In Commercial Distribution 🇺🇸 United States

Planmeca Solanna

DI: 06430035420544 · Model: Solanna · Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Planmeca Solanna
Primary DI
06430035420544
Version / Model
Solanna
Catalog Number
30006329; 30009016
Company Name
Planmeca Oy
Labeler DUNS
368788568
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-01-03
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6ec15b9d-c7b7-4652-bdf0-04206ad43943

Device Description

The Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position. The exceptionally long arm enables optimal working conditions for operations of all kinds.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EAZ Light, Operating, Dental

GMDN Terms

Code Name
56320 LED dental light, line-powered

Identifiers

Type ID
Primary 06430035420544