Aspen® Flexible 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.

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More Product Details

Catalog Number

-

Brand Name

Aspen® Flexible Light Handle Adapter

Version/Model Number

LT-9590X

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

FTA

Product Code Name

Light, surgical, accessories

Device Record Status

Public Device Record Key

1e7855a9-de50-44b7-982d-44b79e685c9f

Public Version Date

March 04, 2021

Public Version Number

5

DI Record Publish Date

September 17, 2016

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