AccessGUDID - DEVICE: Areza Medical (00850021481254)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: SG4X43
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SG4X43
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481254
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel sheet made entirely from medical grade silicone. They are effective for the management of both existing and new, hypertrophic or keloid scars. Areza Silicone Gel Sheet for Scars may also be used as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Not intended to be used on open, unhealed wounds.

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:	No
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?
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
NAD	Dressing, Wound, Occlusive

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry, cool area. Avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ed75ddc-b30f-4696-8e2b-3f465fa32d84
Public Version Date: November 03, 2020
Public Version Number: 1
DI Record Publish Date: October 26, 2020