Duns Number:314482980
Catalog Number
41860-44
Brand Name
4 HOOK & LOOP BAND SIZE S (GENERIC ADAPTER) 3x
Version/Model Number
41860-44
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 2020
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
-
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
K092467
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
1a8663f7-c7ee-4c32-b30e-32953db88298
Public Version Date
May 29, 2020
Public Version Number
2
DI Record Publish Date
March 26, 2020
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 | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 685 |