OBJECTIVE LENS, F=350MM, FIXED - GLOBAL SURGICAL CORPORATION

Duns Number:824793335

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More Product Details

Catalog Number

-

Brand Name

OBJECTIVE LENS, F=350MM, FIXED

Version/Model Number

M 1035

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

EPT

Product Code Name

Microscope, Surgical

Device Record Status

Public Device Record Key

74e47c4c-b286-47c9-8835-43ac82a861a2

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBAL SURGICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 396