Duns Number:014464314
Device Description: Probe Cover, PE, Gel and Elastic bands 15x244cm, 6"x96"
Catalog Number
1006664
Brand Name
Customed
Version/Model Number
1006664
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,K101689
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
7c2b6c0b-99d0-4f94-ba77-20a4cf71afcc
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
December 23, 2019
Package DI Number
00850003355986
Quantity per Package
3
Contains DI Package
10850003355969
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 |