Duns Number:201276334
Device Description: Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27
Catalog Number
025ZS
Brand Name
Lac-Mac
Version/Model Number
025ZS
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031362
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
8c5540d8-c411-4c7a-a92e-2a42a2d9cb25
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
May 28, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 216 |