Duns Number:012430880
Device Description: Hemostat Rochester-Ochsner
Catalog Number
1000665
Brand Name
Henry Schein
Version/Model Number
1000665
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
EMD
Product Code Name
HEMOSTAT, SURGICAL
Public Device Record Key
29d8e318-75e3-4089-a373-0de3b9c95758
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
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 | 3829 |
2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
3 | A medical device with high risk that requires premarket approval | 1 |
U | Unclassified | 34 |