DEVICE: Areza Medical (00850021481032)
Device Identifier (DI) Information
Areza Medical
45334
In Commercial Distribution
45334
ADVANCED MEDICAL ASSOCIATES, LLC
45334
In Commercial Distribution
45334
ADVANCED MEDICAL ASSOCIATES, LLC
Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing.
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: Cool, dry place. Avoid excessive heat |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 2.5 Inch |
Area/Surface Area: 6.25 Square inch |
Width: 2.5 Inch |
Device Record Status
bff40e0f-5f9e-46e2-832c-bf88ce349af0
November 04, 2020
1
October 27, 2020
November 04, 2020
1
October 27, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850021481216
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-931-1387
info@arezamedical.com
info@arezamedical.com