Aspen® Rigid Light Handle Adapter - Intent to be used with Aspen Surgical Disposable - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Intent to be used with Aspen Surgical Disposable light Handle covers.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Aspen® Rigid Light Handle Adapter

Version/Model Number

LT-9873X

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

K020304

Product Code Details

Product Code

FTA

Product Code Name

Light, surgical, accessories

Device Record Status

Public Device Record Key

a2fd43ba-d3e2-481d-9daa-e039f349f454

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASPEN SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 952
2 A medical device with a moderate to high risk that requires special controls. 494