Duns Number:315028238
Device Description: Biopsy forceps, single use sterile, 1,8 x 1.200 mm
Catalog Number
MOA-8
Brand Name
NA
Version/Model Number
MOA-8
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
K170726
Product Code
DWZ
Product Code Name
Device, Biopsy, Endomyocardial
Public Device Record Key
fb020b89-daec-4862-b309-aa17e80cb849
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 23, 2017
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 | 120 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |