Thompson - Instrument Case Rf Tray - THOMPSON SURGICAL INSTRUMENTS, INC.

Duns Number:081334746

Device Description: Instrument Case Rf Tray

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More Product Details

Catalog Number

-

Brand Name

Thompson

Version/Model Number

10050000RFT

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"

Yes

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

K151347

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

71806b49-d13f-4958-bb79-e0c7b1ecfaa7

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

August 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THOMPSON SURGICAL INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4041
2 A medical device with a moderate to high risk that requires special controls. 135