DEVICE: Floseal Hemostatic Matrix (00085412096117)
Device Identifier (DI) Information
Floseal Hemostatic Matrix
1503351
In Commercial Distribution
1503351
BAXTER HEALTHCARE CORPORATION
1503351
In Commercial Distribution
1503351
BAXTER HEALTHCARE CORPORATION
Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| Yes | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47201 | Collagen haemostatic agent, non-antimicrobial |
A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based |
| PMX | Absorbable collagen hemostatic agent with thrombin |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Do Not Freeze |
| Special Storage Condition, Specify: Keep Dry and away from sunlight |
| Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Total Volume: 10 Milliliter |
Device Record Status
d3a15297-f9ca-446a-a78f-eb5480abdf6e
August 10, 2023
5
May 22, 2015
August 10, 2023
5
May 22, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
Medinfo_medproducts@baxter.com