DEVICE: Areza Medical (00850021481001)
Device Identifier (DI) Information
Areza Medical
SSF91010
In Commercial Distribution
SSF91010
ADVANCED MEDICAL ASSOCIATES, LLC
SSF91010
In Commercial Distribution
SSF91010
ADVANCED MEDICAL ASSOCIATES, LLC
Areza Sacral Ultra-Absorbent Foam with Adhesive Border and Flaps consists of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. The multi-layer construction facilitates dynamic fluid management to provide an optimal moist wound environment known to promote faster wound healing. Dynamic fluid management may help reduce the risk of maceration. The gentle silicone layer can significantly minimize pain and trauma to the wound and its surrounding skin during dressing change. The two main absorbent layers- PU foam and ultra-absorbent polyacrylate, provide superior absorption and lock exudates away. The PU backing is waterproof and vapor permeable and may protect against contaminations by external fluids and organisms.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place. Avoid excessive heat |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 9.1 Inch |
Width: 10.2 Inch |
Device Record Status
85b8c2f1-fc8a-49d4-a042-512dc18f537c
November 04, 2024
1
October 26, 2024
November 04, 2024
1
October 26, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00850021481957 | 10 | 00850021481001 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850021481353
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(214) 356-8716
info@arezamedical.com
info@arezamedical.com