Duns Number:080935429
Device Description: Magnetic Drape with Stays,One Neutral Zone
Catalog Number
31140539
Brand Name
Devon
Version/Model Number
31140539
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"
-
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
d2ad140e-85c6-4074-b0f8-2eeed020851c
Public Version Date
May 22, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884527018833
Quantity per Package
20
Contains DI Package
20884527018830
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |