Duns Number:961027315
Device Description: Sterile Sleeve
Catalog Number
599
Brand Name
CONVERTORS
Version/Model Number
599
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 2022
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
LYU
Product Code Name
ACCESSORY, SURGICAL APPAREL
Public Device Record Key
1642c15c-c0ab-478a-a8bd-904612eb49ae
Public Version Date
May 16, 2022
Public Version Number
8
DI Record Publish Date
June 28, 2016
Package DI Number
20885380071741
Quantity per Package
30
Contains DI Package
10885380071744
Package Discontinue Date
May 16, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |