FDA UDI In Commercial Distribution 🇺🇸 United States

Labomed Magna Dental Microscope with ceiling mount / fluorescence observation

DI: 08908006463442 · Model: 6129305 · LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Labomed Magna Dental Microscope with ceiling mount / fluorescence observation
Primary DI
08908006463442
Version / Model
6129305
Company Name
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Labeler DUNS
919049606
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-13
Public Version
1
Public Version Date
2023-06-21
Public Version Status
New
Public Device Record Key
eb986fe9-081b-426d-a6de-1e140635eaf8

Device Description

Same as 6129101 with Ceiling mount (Heavy Duty) (Specify ceiling height at time of ordering) long Arm (1000mm) Magna - Dental Microscope with ceiling mount with fluorescence observation Floor stand with Cross on castor wheels with brakes Galilean Zoom 1:6, convertible to 8 step magnichanger, Zoom range 0.4 - 2.5x 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply 0-210 degree tiltable head, IPD 50-75mm, configured with Rotoplate, DBSi (Double beam splitter inclined), Double iris and DSLR adapter, MaxLite(TM) optics NuVar objective variable focal length 300-400mm with fine focus WF 10x/18mm lockable eyepieces with foldable eyeguards Swivel arm (470mm Long, 360 degree rotation), suspension arm (600mm Long, 320 degree rotation), vertical movement of arm (+/-250mm, light cut - off in park position) ABA (Automatic Balance Arm) with dual handle electro magnetic release for easy drift free positioning Yellow and Green filters, dust cover, and sterilizable knob caps

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
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
FSO Microscope, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
62439 Dental surgical microscope

Identifiers

Type ID
Primary 08908006463442