DEVICE: KerraLite Cool (05060077231252)
Device Identifier (DI) Information
KerraLite Cool
7 x 5in
In Commercial Distribution
CWL1006
CRAWFORD HEALTHCARE LIMITED
7 x 5in
In Commercial Distribution
CWL1006
CRAWFORD HEALTHCARE LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
47764 | Wound hydrogel dressing, non-antimicrobial |
A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
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 out of direct sunlight |
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: less than 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Height: 5 Inch |
Length: 7 Inch |
Device Record Status
68f5981f-7f3d-45f1-9c85-a53a7145fc9c
September 09, 2020
3
October 01, 2019
September 09, 2020
3
October 01, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05060077230613 | 5 | 05060077231252 | In Commercial Distribution | Carton | |
05060077232723 | 40 | 05060077230613 | In Commercial Distribution | Shipper |
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
[?]
+4401565654920
andrew.jackson@acelity.com +4401565654920
elizabeth.woods@acelity.com
andrew.jackson@acelity.com +4401565654920
elizabeth.woods@acelity.com