DEVICE: Areza Medical (00850021481049)
Device Identifier (DI) Information
Areza Medical
45330
In Commercial Distribution
45330
ADVANCED MEDICAL ASSOCIATES, LLC
45330
In Commercial Distribution
45330
ADVANCED MEDICAL ASSOCIATES, LLC
Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a superior absorbent dressing for moderate to high wound exudates management. This sterile dressing helps maintain a moist wound healing environment with no irritation upon removal, minimizes trauma to the wound, and reduces pain during dressing changes. The advanced multi-layer design helps provide high breathability to reduce the risk of maceration and protects against external bacteria.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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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 |
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Special Storage Condition, Specify: Store in dry, cool place. Avoid excessive heat. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 4.15 Inch |
Width: 4.15 Inch |
Device Record Status
f36547d1-222b-41f4-a56f-bbb885b1d4ee
November 03, 2020
1
October 26, 2020
November 03, 2020
1
October 26, 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:
00850021481209
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-931-1387
info@arezamedical.com
info@arezamedical.com