Catalog Number
8476
Brand Name
CONVERTORS
Version/Model Number
8476
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 05, 2023
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
afcd54e5-5005-46ba-8e23-bc65bb1ce064
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
August 20, 2019
Package DI Number
50192253020746
Quantity per Package
24
Contains DI Package
00192253020741
Package Discontinue Date
June 05, 2023
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 |