Duns Number:083171244
Device Description: ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM
Catalog Number
1692-ZL
Brand Name
Helitene®
Version/Model Number
1692-ZL
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
d8471f71-805b-464d-80a7-2db79cbf44dd
Public Version Date
April 19, 2021
Public Version Number
7
DI Record Publish Date
September 11, 2014
Package DI Number
10381780000228
Quantity per Package
5
Contains DI Package
00381780000221
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 |