DEVICE: Hemostasyl (10841396117135)
Device Identifier (DI) Information
Hemostasyl
34723
In Commercial Distribution
KERR CORPORATION
34723
In Commercial Distribution
KERR CORPORATION
Hemostatic Dressing with Mechanical Action - Syringe Refill
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVL | CORD, RETRACTION |
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: Store at temperature < 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 4 Gram |
Device Record Status
688ad7c4-5471-409d-b1ef-763530ba5126
March 29, 2018
2
August 31, 2016
March 29, 2018
2
August 31, 2016
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:
00841396117138
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+18005377123
customercare@kavokerrgroup.com
customercare@kavokerrgroup.com