Duns Number:961027315
Device Description: SmartSleeve Surgical Gown, XL. Polyreinforced Surgical Gown
Catalog Number
9041
Brand Name
CONVERTORS
Version/Model Number
9041
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General surgery tray
Public Device Record Key
d4bbad67-d40e-465c-8ec9-7e2446eb6627
Public Version Date
June 20, 2019
Public Version Number
1
DI Record Publish Date
June 12, 2019
Package DI Number
50885380172494
Quantity per Package
20
Contains DI Package
10885380172496
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 | 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 |