Duns Number:058614483
Device Description: Ultrasound Probe Cover,6"" x 96"" (15.2 cm x 2.4 m)
Catalog Number
-
Brand Name
ClosureFast
Version/Model Number
PC-6X96
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 20, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K882724,K882724
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
caa4dba7-8c8b-418a-b08e-d78d7d9a7abe
Public Version Date
May 05, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20884521058122
Quantity per Package
20
Contains DI Package
10884521058125
Package Discontinue Date
November 20, 2020
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |