Duns Number:027680821
Device Description: Provides a sterile interface between the operating room surgical lamps (non-sterile) and t Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).
Catalog Number
-
Brand Name
Sterion®Clamp Cover Fabric
Version/Model Number
061011PBX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2022
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
705394a0-10f2-4e79-94e2-8a00a98eac95
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
December 12, 2018
Package DI Number
10887761000374
Quantity per Package
10
Contains DI Package
00887761000377
Package Discontinue Date
April 01, 2022
Package Status
Not 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 |