Thompson - Micro Adj II Clip-On QA 10" REV - THOMPSON SURGICAL INSTRUMENTS, INC.

Duns Number:081334746

Device Description: Micro Adj II Clip-On QA 10" REV

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More Product Details

Catalog Number

-

Brand Name

Thompson

Version/Model Number

SL6980

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

04b80ad4-2d5f-4fd1-96e0-e1e757451ce7

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

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