Duns Number:027680821
Device Description: Intent to be used with Aspen Surgical Disposable light Handle covers.
Catalog Number
-
Brand Name
Aspen® Rigid Light Handle Adapter
Version/Model Number
LT-9730A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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,K020304
Product Code
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
b794a979-ff52-423b-9708-516aa617e07b
Public Version Date
April 06, 2022
Public Version Number
2
DI Record Publish Date
February 25, 2021
Package DI Number
00840113224319
Quantity per Package
1
Contains DI Package
00840113224302
Package Discontinue Date
February 25, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| 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 |