Case Medical - Sterilization Case Flexible Surgical Fiber - CASE MEDICAL INC.

Duns Number:053057972

Device Description: Sterilization Case Flexible Surgical Fiber (60x28x11) basket insert

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More Product Details

Catalog Number

STF-SFS-B

Brand Name

Case Medical

Version/Model Number

STF-SFS-B

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

1fcdfe54-0d5c-4d75-a3db-a5bba2a68a6e

Public Version Date

February 09, 2022

Public Version Number

1

DI Record Publish Date

February 01, 2022

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