Duns Number:177360039
Device Description: ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solutio ORLocate HoveRead Drape with two straps, sterile is used with the ORLocate Sponge Solution System.
Catalog Number
HC12631
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
873e3bbd-c6b3-40ba-938a-640e61188d18
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
Package DI Number
55060356150026
Quantity per Package
50
Contains DI Package
05060356150021
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 |