Duns Number:817435655
Device Description: Lateral and Prone Access Drape SPD-18-001
Catalog Number
SPD-18-001
Brand Name
DAS
Version/Model Number
SPD-18-001
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)
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
43f46732-481b-4779-b53e-00a5f3e62e1c
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 19, 2021
Package DI Number
17466532979038
Quantity per Package
2
Contains DI Package
07466532979031
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |