CASE MEDICAL - ROBOTIC STEALTH™ NAVIGATION REFERENCE CONTAINER - CASE MEDICAL INC.

Duns Number:053057972

Device Description: ROBOTIC STEALTH™ NAVIGATION REFERENCE CONTAINER SET

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More Product Details

Catalog Number

9736084

Brand Name

CASE MEDICAL

Version/Model Number

9736084

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)

-

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

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

89487ffe-0c92-4c71-b6e9-b7ae3f698f1d

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

March 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CASE MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 278