DEVICE: Areza Medical (00850021481001)

Device Identifier (DI) Information

Areza Medical
SSF91010
In Commercial Distribution
SSF91010
ADVANCED MEDICAL ASSOCIATES, LLC
00850021481001
GS1

10
047724226 *Terms of Use
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.
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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
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, Wound, Occlusive
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place. Avoid excessive heat
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Clinically Relevant Size

[?]
Size Type Text
Length: 9.1 Inch
Width: 10.2 Inch
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Device Record Status

85b8c2f1-fc8a-49d4-a042-512dc18f537c
November 04, 2024
1
October 26, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00850021481353 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(214) 356-8716
info@arezamedical.com
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