Labomed Prima Mu ENT microscope

GUDID 08908006463213

Labomed Prima Mu ENT microscope - '- MaxLite(TM) optics,3 step magnification: 0.6x, 1.0x, 1.6x - 27W LED illumination (cold light), 100V-240V AC universal power supply - Straight binocular head, IPD 50-75mm - f=250mm CMO with manual fine focus knob and sterilizable cap - WF 10x/18mm eyepieces with foldable eyeguard - Swivel arm (380mm Long, 360° rotation), suspension arm (600mm Long, clockwise 70° and - 180° rotation) with locking/tension control knobs and LED shut-off in park position - Carrier arm and ± 155° coupling with tension adjustment locks - Floor stand with H-shape base on castor wheels with brakes - Yellow or Green filter, dust cover, and sterilizable knob caps

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope General-purpose surgical microscope
Primary Device ID08908006463213
NIH Device Record Key974d801d-0a91-4289-9e94-34c8be387604
Commercial Distribution StatusIn Commercial Distribution
Brand NameLabomed Prima Mu ENT microscope
Version Model Number6212000
Company DUNS919049606
Company NameLABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108908006463213 [Primary]

FDA Product Code

FSOMicroscope, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

Devices Manufactured by LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

08908006463497 - LABOMED SLx 40- 3 Step Slit lamp -HL (Halogen)2023-06-26
08908006463503 - LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)2023-06-26
08908006463510 - LABOMED SLx 40- 3 Step Slit lamp -LED2023-06-26
08908006463527 - LABOMED SLx 45- 3 Step Slit lamp -LED2023-06-26
08908006463534 - LABOMED eVO300 5-Step Slit lamp -Halogen (HL)2023-06-26
08908006463541 - LABOMED eVO400 5-Step Slit lamp -Halogen (HL)2023-06-26
08908006463558 - LABOMED eVO300 5-Step Slit lamp -LED2023-06-26
08908006463565 - LABOMED eVO400 5-Step Slit lamp -LED2023-06-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.