Duns Number:121622872
Device Description: TRAY, BMET-11ANL, F/G PN 74075-02M
Catalog Number
BMET-11ANL
Brand Name
BMET-11ANL, F/G
Version/Model Number
11 Gauge x 4"
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
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
K983187,K983187
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
5609bac4-19d1-4ca4-a5b1-247f3c309330
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 02, 2018
Package DI Number
M9797407502M9
Quantity per Package
10
Contains DI Package
M9797407502M0
Package Discontinue Date
-
Package Status
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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 93 |