Duns Number:177360039
Device Description: ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solu ORLocate HoveRead Drape with two straps, non-sterile is used with the ORLocate Sponge Solution System.
Catalog Number
HC12631NS
Brand Name
ORLocate
Version/Model Number
ORLocate Drape
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
a3efdac0-c618-4811-b9cd-f7af48613618
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
Package DI Number
55060356150033
Quantity per Package
10
Contains DI Package
15060356150035
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |