AccessGUDID - DEVICE: Areza Medical (00850021481339)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: AGF4255
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AGF4255
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic silver particles. The dressing contains 0.35~0.40mg/cm3 (17.3~20.1 mg/100cm2) of ionic silver. The high absorbency, along with antibacterial properties, qualify Areza Medical Silver Foam Dressing as a very useful dressing indicated for exudate absorption and the management of partial to full thickness wounds. The dressing provides proper moist wound healing environment.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 at room temperature, avoid extreme heat.

Clinically Relevant Size

[?]

Size Type Text
Width: 4.25 Inch
Length: 4.25 Inch
Height: 5 Millimeter

Device Record Status

Public Device Record Key: 36b1b614-e5c8-4441-8e1f-9a8f24cf9f0e
Public Version Date: March 30, 2021
Public Version Number: 1
DI Record Publish Date: March 22, 2021