Areza Medical ST15501

GUDID 00810147400157

AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoallergenic nature and ease of removal make it an ideal tape for patients with fragile skin or sensitivity to acrylic adhesives. Areza Silicone Tape consists of a polyurethane film carrier (backing) and a potent adhesive silicone gel. The combination of strong adhesion and skin-friendliness makes this tape ideal for applications requiring a secure hold without causing skin irritation. This tape finds versatile applications in various healthcare settings and conditions, providing extended wear time. It is commonly used in wound care, post-surgery recovery, and medical device fixation, among other healthcare applications.

ADVANCED MEDICAL ASSOCIATES, LLC

Dressing-fixation skin adhesive tape, non-silicone
Primary Device ID00810147400157
NIH Device Record Key798f8dd4-d514-431c-a0f1-4d6e198606eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreza Medical
Version Model NumberST15501
Catalog NumberST15501
Company DUNS047724226
Company NameADVANCED MEDICAL ASSOCIATES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com
Phone(214) 356-8716
Emailinfo@arezamedical.com

Device Dimensions

Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch
Length5.46 Yard
Width1 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid excessive heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100810147400157 [Package]
Contains: 00850021481636
Package: Inner case [6 Units]
In Commercial Distribution
GS100810147400164 [Package]
Contains: 00850021481636
Package: Case [120 Units]
In Commercial Distribution
GS100850021481636 [Primary]

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-01
Device Publish Date2024-06-22

On-Brand Devices [Areza Medical]

00850021481148Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed
00850021481070Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (2 Roll)is composed of a soft, p
00850021481322Foam dressings are sheets of foamed polymer solutions (most commonly polyurethane) with small, o
00850021481308Areza Island Wound Dressing (Bordered Gauze) is a non-adherent, minimally absorptive, and self a
00850021481261Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel s
00850021481186Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, with a
00850021481162Areza Calcium Alginate Wound Dressing 4.25" x 4.25" (10) Areza Calcium Alginate is made of natu
00850021481049Ultra-Absorbent Silicone Foam with Adhesive Border 6" x 6" (pad: 4.15" x 4.15") is a superior ab
00850021481285Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a centr
00850021481247Showerproof Transparent Adhesive Film 4" x 4.7" consist of a thin polyurethane (PU) film, with a
00850021481094Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (12 Roll) is composed of a soft,
00850021481087Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (3 Roll) is composed of a soft,
00850021481056Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wou
00850021481032Ultra-Absorbent Silicone Foam with Adhesive Border 4" x 4" (pad: 2.5" x 2.5") - consist of a fen
00850021481063Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (1 Roll) is composed of a soft,
00850021481346Areza Silver Foam Dressing is composed of polyurethane (PU) foam coated with antibacterial ionic
00850021481025Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 7" x 6.8"
00850021481360Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border 9.2" x 9.2"
00850021481537Sacral Dressing Ultra-Absorbent Silicone Foam with Adhesive Border and Flaps 7.2" x 7.8" Box of
00850021481599Areza Carboxymethyl Cellulose(CMC) Gelling Fiber 4.25” x 4.25” (10.75 x 10.75 cm) 10 pcs
00810147400171AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle
00810147400157AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle
00810147400195AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoalle

Trademark Results [Areza Medical]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AREZA MEDICAL
AREZA MEDICAL
87720350 not registered Live/Pending
Advanced Medical Associates LLC
2017-12-14

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