DEVICE: Labomed Prima Mu ENT microscope (08908006463213)

Device Identifier (DI) Information

Labomed Prima Mu ENT microscope
6212000
In Commercial Distribution

LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
08908006463213
GS1

1
919049606 *Terms of Use
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
CLOSE

Device Characteristics

MR Safe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35191 General-purpose surgical microscope
A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FSO Microscope, Surgical, General & Plastic Surgery
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

974d801d-0a91-4289-9e94-34c8be387604
June 22, 2023
1
June 14, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE