Duns Number:830016148
Device Description: 3M™ Steri-Drape™ Instrument Table Cover, Reinforced 9077R
Catalog Number
9077R
Brand Name
Steri-Drape™
Version/Model Number
9077R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2019
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
5009c0f4-2a0c-4b27-b274-abe2c3d3dd63
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
50707387579604
Quantity per Package
2
Contains DI Package
30707387579600
Package Discontinue Date
October 31, 2019
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |