Duns Number:342243334
Device Description: 6.5mm Washer s/s for 2.7mm screws
Catalog Number
932999015
Brand Name
6.5mm Washer s/s for 2.7mm screws
Version/Model Number
932999015
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
-
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
5a517808-55bb-4461-b415-ba438f918619
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 04, 2016
Package DI Number
EMAH9329990151
Quantity per Package
1
Contains DI Package
EMAH9329990150
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 |