Duns Number:083171244
Device Description: ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, 3IN X 4IN, 5MM THICK
Catalog Number
3410-ZX
Brand Name
Helistat ® ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Version/Model Number
3410-ZX
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
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
P850010,P850010
Product Code
LMF
Product Code Name
Agent, Absorbable Hemostatic, Collagen Based
Public Device Record Key
5bdb799d-5d44-46d7-8378-a1d5ad5cdd69
Public Version Date
September 22, 2020
Public Version Number
5
DI Record Publish Date
September 11, 2014
Package DI Number
10381780000204
Quantity per Package
10
Contains DI Package
00381780000207
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |