Duns Number:014464314
Device Description: ORI-Specialty Drape Line Direct Anterior Hip
Catalog Number
ORI-SDL-DAHIP
Brand Name
ORI
Version/Model Number
ORI-SDL-DAHIP
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
27acce74-2bc3-4587-aa7e-af0558476917
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
October 22, 2019
Package DI Number
00850003355672
Quantity per Package
5
Contains DI Package
00850003355665
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 489 |