Duns Number:342243334
Device Description: Blakesley biopsy fcps.insert,5/330mm
Catalog Number
088.33
Brand Name
Blakesley biopsy fcps.insert,5/330mm
Version/Model Number
088.33
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
950a9801-6451-442e-8036-8221fd711fe8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2016
Package DI Number
EMAH088331
Quantity per Package
1
Contains DI Package
EMAH088330
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 |