Duns Number:027680821
Device Description: Intended to be used to standardize OR Cameras to allow for the use of the OR Camera Cover
Catalog Number
-
Brand Name
Aspen® O.R. Camera Cover Adapter
Version/Model Number
LT-9904
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
-
Product Code
KQM
Product Code Name
CAMERA, SURGICAL AND ACCESSORIES
Public Device Record Key
92fbcbe3-d7fb-4a52-83bd-4fb45d221f6e
Public Version Date
March 19, 2021
Public Version Number
2
DI Record Publish Date
February 25, 2021
Package DI Number
00840113205516
Quantity per Package
1
Contains DI Package
00840113205509
Package Discontinue Date
-
Package Status
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 |