Areza Medical

Primary DI
00850021481049
Brand
Areza Medical
Company
ADVANCED MEDICAL ASSOCIATES, LLC
Model
45330
Catalog number
45330
Device description
"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."
Published
2020-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021481049PrimaryGS10
00850021481209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021481049008500214810498500214810490850021481049
00850021481209008500214812098500214812090850021481209

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.15Inch
Width4.15Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry, cool place. Avoid excessive heat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-931-1387info@arezamedical.com

Regulatory Flags#

DUNS number
047724226
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021481766Areza MedicalRT4X11RT4X112024-11-07
00810147400225Areza MedicalCOPOVV10COPOVV102024-10-26
00810147400263Areza MedicalCOPOV10COPOV102024-10-26
00810147400546Areza MedicalCMC42520CMC425202024-10-26
00850021481001Areza MedicalSSF91010 SSF91010 2024-10-26
00850021481674Areza MedicalBG8430 BG84302024-10-26
00850021481728Areza MedicalBG8630BG86302024-10-26
00850021481742Areza MedicalAGF42510AGF425102024-10-26
00850021481759Areza MedicalAGF42520AGF425202024-10-26
00850021481773Areza MedicalSA42520SA425202024-10-25
00850021481810Areza MedicalSA425100SA4251002024-10-25
00850021481902Areza MedicalF5410F54102024-10-26
00810147400232Areza MedicalCOPOVV10COPOVV102024-10-26
00810147400270Areza MedicalCOPOV10COPOV102024-10-26
00850021481957Areza MedicalSSF91010 SSF91010 2024-10-26
00810147400836Areza MedicalBG8430 BG84302024-10-26
00810147400850Areza MedicalBG8630BG86302024-10-26
00850021481865Areza MedicalAGF42510AGF425102024-10-26
00850021481827Areza MedicalAGF42520AGF425202024-10-26
00850021481841Areza MedicalSA42520SA425202024-10-25

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