Duns Number:961027315
Device Description: EENT Split Sheet, Large
Catalog Number
9447
Brand Name
CONVERTORS
Version/Model Number
9447
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
ERY
Product Code Name
Drape, surgical, ent
Public Device Record Key
dea681d1-7cb0-4a2a-a96c-971150587c38
Public Version Date
December 31, 2021
Public Version Number
8
DI Record Publish Date
January 17, 2018
Package DI Number
50885380117884
Quantity per Package
8
Contains DI Package
10885380117886
Package Discontinue Date
December 31, 2021
Package Status
Not 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 |