Duns Number:961027315
Device Description: Incise Drape
Catalog Number
D1035
Brand Name
CONVERTORS
Version/Model Number
D1035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 26, 2024
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
cbe8c3e3-ef9b-44f0-aba3-419110f4686d
Public Version Date
January 14, 2022
Public Version Number
7
DI Record Publish Date
July 08, 2016
Package DI Number
50885380065833
Quantity per Package
10
Contains DI Package
10885380065835
Package Discontinue Date
November 26, 2024
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |