Duns Number:342243334
Device Description: Foreign body fcps.,alligator 5Fr.,400mm, semi-rigid
Catalog Number
35.010.015SR
Brand Name
Foreign body fcps.,alligator 5Fr.,400mm, semi-rigid
Version/Model Number
35.010.015SR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
FCL
Product Code Name
FORCEPS, BIOPSY, NON-ELECTRIC
Public Device Record Key
93a48062-9b96-4840-8992-4aab7bad493d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2016
Package DI Number
EMAH35010015SR1
Quantity per Package
1
Contains DI Package
EMAH35010015SR0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |