Duns Number:327681359
Device Description: MICRO APPROXIMATOR CLAMP FOR ARTERY LENGTH 36 MM; Ø VESSEL 2,0 - 5,0 MM CODE: RD-D 5A MICRO APPROXIMATOR CLAMP FOR ARTERY LENGTH 36 MM; Ø VESSEL 2,0 - 5,0 MM CODE: RD-D 5A
Catalog Number
64.455.01
Brand Name
LAZIC
Version/Model Number
64.455.01
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
-
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
HXD
Product Code Name
Clamp
Public Device Record Key
c56b1027-37d4-48f2-afd5-f8f01105a956
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |