Duns Number:080935429
Device Description: True content to be populated as part of rebranding
Catalog Number
52000040
Brand Name
Devon
Version/Model Number
52000040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2019
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
K040052,K040052
Product Code
HFX
Product Code Name
CLAMP, CIRCUMCISION
Public Device Record Key
4b2fac35-8dcf-44cb-86d1-75013155a30d
Public Version Date
July 01, 2019
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
10884527023127
Quantity per Package
20
Contains DI Package
20884527023124
Package Discontinue Date
July 01, 2019
Package Status
Not 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 |