KerraLite Cool Border

Basic Information

• Brand Name: KerraLite Cool Border
• Primary DI: 05060077231276
• Version / Model: 4x4in
• Catalog Number: CWL1008
• Company Name: CRAWFORD HEALTHCARE LIMITED
• Labeler DUNS: 543740310
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 3
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 20ceea7c-3fcc-40ad-904b-77055bf194d4

Device Description

Soothing, debriding and moisture-balancing dressing.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060077230668	GS1	Carton	5	In Commercial Distribution
Primary	05060077231276	GS1
Package	05060077233805	GS1	Shipper	550	In Commercial Distribution
Package	05060077232747	GS1	Shipper	52	In Commercial Distribution

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Height	4	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Store out of direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit