Duns Number:027680821
Device Description: Intended to standardize OR Cameras to allow for the use of the OR Camera Cover
Catalog Number
-
Brand Name
Aspen® O.R. Camera Cover
Version/Model Number
LT-C02
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
Yes
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
1e9363d8-d747-47b3-8953-d4020d75fbb3
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 28, 2021
Package DI Number
00840113219971
Quantity per Package
20
Contains DI Package
00840113219964
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 |