Duns Number:604056226
Device Description: Sterile Labels - Sterile Labels - Custom, 10 labels/panel, 2 panels/pouch, 100 pouches/Box
Catalog Number
-
Brand Name
Key Surgical Sterile Labels
Version/Model Number
SL-208
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYV
Product Code Name
Label Or Tag, Sterile
Public Device Record Key
adf6dd56-802f-4977-b7e1-5335c63e0750
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
December 21, 2020
Package DI Number
00849771033516
Quantity per Package
100
Contains DI Package
00849771025696
Package Discontinue Date
-
Package Status
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |