Duns Number:830016148
Device Description: 3M™ Steri-Drape™ Large Ophthalmic Sheet with Incise Film and Pouches, 1055B, 14/Carton 2 C 3M™ Steri-Drape™ Large Ophthalmic Sheet with Incise Film and Pouches, 1055B, 14/Carton 2 Carton/Case
Catalog Number
1055B
Brand Name
3M™ Steri-Drape™
Version/Model Number
1055B
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
e827d9fc-c6ee-4941-8f52-880c381e27c7
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 23, 2021
Package DI Number
50707387807462
Quantity per Package
2
Contains DI Package
30707387807468
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |