FDA.report

Gynex

Primary DI
GYNXMI60000
Brand
Gynex
Company
GYNEX CORPORATION
Model
MI-6000
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IBJLight, Microscope

Product Code Classifications

CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
GYNXMI60000PrimaryHIBCC0

GMDN Terms

TermDefinition
Basic light microscopeA magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012997685
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26
GYNX298000Gynex29-8002023-12-26
GYNX298500Gynex29-8502023-12-26
GYNX299000Gynex29-9002023-12-26
GYNX31300Gynex31302023-12-26
GYNX31350Gynex31352023-12-26
GYNX32050Gynex32052023-12-26
GYNX32070Gynex32052023-12-26
GYNXNHL34500GynexNHL34502023-12-26
GYNXNHMH3410140GynexNHMH3410-142023-12-26
GYNXNHMH3410160GynexNHMH3410-162023-12-26
GYNXNHMH3410180GynexNHMH3410-182023-12-26
GYNXNHMH3410200GynexNHMH3410-202023-12-26
GYNXNHW34000GynexNHW34002023-12-26
GYNXS0010GynexS0012023-12-26

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