Duns Number:081277700
Device Description: ABSORBABLE COLLAGEN HEMOSTATIC AGENT FIBRILLAR FORM, 0.5GRAM
Catalog Number
1984
Brand Name
INSTAT* MCH Microfibrillar Collagen Hemostat
Version/Model Number
1984
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
P810006,P810006,P810006
Product Code
LMF
Product Code Name
Agent, Absorbable Hemostatic, Collagen Based
Public Device Record Key
3f688aa3-dccf-438f-ab8a-eba1c752eba0
Public Version Date
March 09, 2021
Public Version Number
6
DI Record Publish Date
September 11, 2014
Package DI Number
30705031003198
Quantity per Package
3
Contains DI Package
20705031003191
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |