AccessGUDID - DEVICE: FLOSEAL HEMOSTATIC MATRIX (00085412656304)

GUDID

Device Identifier (DI) Information

Brand Name: FLOSEAL HEMOSTATIC MATRIX
Version or Model: ADS201883
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADS201883
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412656304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 628013963 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PMX	Absorbable collagen hemostatic agent with thrombin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990009	053
P990009	061

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not freeze. Keep dry and away from sunlight.
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 50bb92ba-a4cf-4166-848d-839427ce9717
Public Version Date: August 10, 2023
Public Version Number: 7
DI Record Publish Date: May 31, 2019