AccessGUDID - DEVICE: KerraMax Care (05060077232143)

GUDID

Device Identifier (DI) Information

Brand Name: KerraMax Care
Version or Model: 8 x 9in
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD500-300
Company Name: CRAWFORD HEALTHCARE LIMITED

Primary DI Number: 05060077232143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543740310 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store away from direct sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 9 Inch
Height: 8 Inch

Device Record Status

Public Device Record Key: 1052d0c1-4bfd-4509-b68f-7f85a498c14d
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: October 01, 2019