Model: 572
Catalog: 572
DI: 10841495149679
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
64b8e3b0-2fe1-49bc-a5f9-62dd90cedff5
Distribution Status:
In Commercial Distribution
DUNS Number:
002348191
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CS
Item #1 - Device ID:
30841495149673
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10841495149679
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10841495149679
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 47917
Name: Non-organic haemostatic agent
Definition:
A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis through formation of a sealant and/or clot acceleration; it might additionally be intended to absorb bodily fluids. It is available in various forms (e.g., powder, gel, impregnated gauze) intended to be applied directly or endoscopically to the wound temporarily; it does not contain an antimicrobial agent. Disposable manual or electronic devices for application may be included. This is a single-use device.
FDA Product Codes
QSY
Hemostatic wound dressing without thrombin or other biologics
Premarket Submissions
Submission Number:
K072474
Supplement Number:
000