M844 F20 / M822 F20 - F20 stand system for M844 / M822 - for Leica - Leica Microsystems (Schweiz) AG

Duns Number:480198725

Device Description: F20 stand system for M844 / M822 - for Leica surgical operating microscope systems: M844 F F20 stand system for M844 / M822 - for Leica surgical operating microscope systems: M844 F20, M822 F20

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More Product Details

Catalog Number

-

Brand Name

M844 F20 / M822 F20

Version/Model Number

000000000010448596

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSO

Product Code Name

MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

cae91cea-b71f-4512-a200-f7175c3c8078

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEICA MICROSYSTEMS (SCHWEIZ) AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 8