Duns Number:014464314
Device Description: Universal Light Handle Cover
Catalog Number
POSS-6504
Brand Name
POSS
Version/Model Number
POSS-6504
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
K101689,K101689
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
69ad25fd-5755-4e1a-a305-4ceac9c6a4dc
Public Version Date
October 14, 2021
Public Version Number
1
DI Record Publish Date
October 06, 2021
Package DI Number
00850337007506
Quantity per Package
100
Contains DI Package
00850337007490
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 489 |