Aspen® O.R. Camera Cover Adapter - Intended to be used to standardize OR Cameras to - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: Intended to be used to standardize OR Cameras to allow for the use of the OR Camera Cover

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More Product Details

Catalog Number

-

Brand Name

Aspen® O.R. Camera Cover Adapter

Version/Model Number

LT-9900

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

KQM

Product Code Name

CAMERA, SURGICAL AND ACCESSORIES

Device Record Status

Public Device Record Key

10a0db9b-22f6-422a-b3d6-c6f1ed76b1d1

Public Version Date

March 19, 2021

Public Version Number

2

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