AnyPlus® - AnyPlus MIS NX Instruments Tray - GS Medical Co., Ltd.

Duns Number:688385418

Device Description: AnyPlus MIS NX Instruments Tray

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More Product Details

Catalog Number

US114-9990

Brand Name

AnyPlus®

Version/Model Number

US114-9990

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

617ac069-e207-456c-9ea6-07f15ffddb39

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GS MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 7396