FDA.reportPublic FDA data

Areza Medical

Primary DI
00810147401208
Brand
Areza Medical
Company
ADVANCED MEDICAL ASSOCIATES, LLC
Model
TF8610
Catalog number
TF8610
Device description
"Transparent Adhesive Film Dressing - 8"" x 6"" (10) consists of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to the skin. They are breathable, sterile, transparent, and water-resistant. It may be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants."
Published
2024-10-11
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
00810147401215PackageGS112In Commercial Distribution
00810147401222PackageGS124In Commercial Distribution
00810147401208PrimaryGS10
00810147401192Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810147401215008101474012158101474012150810147401215
00810147401222008101474012228101474012220810147401222
00810147401208008101474012088101474012080810147401208
00810147401192008101474011928101474011920810147401192

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer semi-permeable film dressing, adhesiveA transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. 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, Specify00Cool, dry place. Avoid excessive heat

Contacts#

Phone, Email table
PhoneEmail
(214) 356-8716info@arezamedical.com

Regulatory Flags#

DUNS number
047724226
Device count
10
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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