FDA.reportPublic FDA data

Areza Medical

Primary DI
00810147400850
Brand
Areza Medical
Company
ADVANCED MEDICAL ASSOCIATES, LLC
Model
BG8630
Catalog number
BG8630
Device description
Areza Island Wound Dressing (Bordered Gauze) is a sterile and self-adhesive dressing. The central pad (6"x4") is made of non-woven viscose fibers with a non-adherent fenestrated layer for wound contact. The backing (8"x6") is composed of polyurethane and Spunlace fabric with adhesive. This dressing is ideal for minimally exuding wounds, reducing the risk of damage and other contaminations. Individually packed and sterile for convenience.
Published
2024-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

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
00810147400850PackageGS110In Commercial Distribution
00810147400867PackageGS120In Commercial Distribution
00850021481728PrimaryGS10
00850021481711Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810147400850008101474008508101474008500810147400850
00810147400867008101474008678101474008670810147400867
00850021481728008500214817288500214817280850021481728
00850021481711008500214817118500214817110850021481711

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
Length8Inch
Width6Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047724226
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850021481865Areza MedicalAGF42510AGF425102024-10-26
00850021481827Areza MedicalAGF42520AGF425202024-10-26
00850021481841Areza MedicalSA42520SA425202024-10-25
00850021481872Areza MedicalSA425100SA4251002024-10-25

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