AccessGUDID - DEVICE: Areza Medical (00850021481773)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: SA42520
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA42520
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: The dressing is made from natural alginate fibers and silver. Silver particle in the dressing can restrain growth of biologic pathogens in the wound and help reduce further wound infection. The dressing has been tested in vitro and found to be effective against several important biologic pathogens affecting wounds. It is designed to be highly absorbent. The dressing, while absorbing wound drainage (exudates), forms a gel-like covering over the wound, which provides an ideal moist environment. Moist wound healing is known to expedite wound healing. The gel-like surface also prevents the dressing from adhering to the wound, making removal painless.

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):	No
Over the Counter (OTC):	Yes
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?
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. 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 in cool, dry place. Avoid excessive heat

Clinically Relevant Size

[?]

Size Type Text
Length: 4.25 Inch
Width: 4.25 Inch

Device Record Status

Public Device Record Key: bca306f7-e15c-4456-83c6-fbbdfd3ca64d
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 25, 2024