DEVICE: Hemostasyl (10841396117135)

Device Identifier (DI) Information

Hemostasyl
34723
In Commercial Distribution

KERR CORPORATION
10841396117135
GS1

2
847905890 *Terms of Use
Hemostatic Dressing with Mechanical Action - Syringe Refill
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
61905 Inorganic haemostatic agent, non-sterile
A non-sterile, non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., aluminium chloride) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to facilitate local haemostasis by creating a physical barrier to bleeding and/or clot acceleration; it may also be intended to absorb bodily fluids and does not contain an antimicrobial agent. It is available in various forms (e.g., solution, powder, gel) and can be applied directly or endoscopically to the wound where it forms a seal until physically removed; various disposable applicators may be included. This is a single-use device.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MVL CORD, RETRACTION
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at temperature < 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Weight: 4 Gram
CLOSE

Device Record Status

688ad7c4-5471-409d-b1ef-763530ba5126
March 29, 2018
2
August 31, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00841396117138 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+18005377123
customercare@kavokerrgroup.com
CLOSE