Duns Number:612611459
Device Description: Dura Separator, Baker, Reusable Set Consisting Of One Each #0 Cat#800-715 ID#008106070005 Dura Separator, Baker, Reusable Set Consisting Of One Each #0 Cat#800-715 ID#00810607000576,#1 Cat#800-716 ID#00810607000583,#2 Cat#800-717 ID#00810607000590,#3 Cat#800-718 ID#00810607000606
Catalog Number
800-719
Brand Name
Dura Separator, Baker, Reusable
Version/Model Number
800-719
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAO
Product Code Name
Instrument, Surgical, Non-Powered
Public Device Record Key
b7c69450-6662-456a-8ef3-bc8a6be19334
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2017
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |