Duns Number:080935429
Device Description: 7400-JMH Basin Accessory Kit. Caution: For processing, repacking or manufacturing.
Catalog Number
573357B
Brand Name
Devon
Version/Model Number
573357B
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
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
43a48cfe-a51d-4807-bd88-486acc1623c9
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
June 27, 2018
Package DI Number
10884521201958
Quantity per Package
8
Contains DI Package
10884521741553
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |