Duns Number:014464314
Device Description: Sterile Dual Fenstrated Drape
Catalog Number
10601006
Brand Name
Exact Medical Manufacturing
Version/Model Number
10601006
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)
-
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
c72c6b0e-a1a6-45c7-8b2a-212a77f4d845
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 29, 2018
Package DI Number
10852205007950
Quantity per Package
24
Contains DI Package
00852205007953
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 |