Duns Number:042763706
Device Description: DRAPE POLYTISSUE W/TIE 40X52 NS 12/PKG DISPOSABLE 5PKG/CA L/F
Catalog Number
0034100
Brand Name
ACE
Version/Model Number
0034100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
a30186d3-6096-403e-91fe-70235ccb6b5b
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2015
Package DI Number
10614950000088
Quantity per Package
12
Contains DI Package
00614950000081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvec Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |