FDA.reportPublic FDA data

Protect U Guard Non-Woven Dressing

Primary DI
B086191241
Brand
Protect U Guard Non-Woven Dressing
Company
PROTECT U GUARD, LLC
Model
P29124
Device description
Protect U Guard Non-Woven Dressing 7x9cm Oval Eye
Published
2020-08-21
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
B0862191242PackageHIBCC1000In Commercial Distribution
B086191241PrimaryHIBCC0
B086091240Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Centimeter
Width7Centimeter

Contacts#

Phone, Email table
PhoneEmail
8138150530sales@protectuguard.com

Regulatory Flags#

DUNS number
080070945
Device count
50
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B086191501Protect U Guard U-Shaped IV Transparent DressingP191502020-08-21
B086191511Protect U Guard Transparent Sterile DressingP191512020-08-21
B086191541Protect U Guard Transparent Sterile Dressing PU InciseP191542020-08-21
B086202012Protect U Guard Bouffant Cap BlueP202012017-02-24
B086202022Protect U Guard Bouffant Cap YellowP202022017-02-24
B086203012Protect U Guard Doctor Cap BlueP203012017-02-24
B086191311Protect U Guard Silicone Foam Sterile DressingP191312020-08-21
B086191321Protect U Guard Silicone Foam Sterile DressingP191322020-08-21
B086105051Protect U Guard CPE Isolation GownP105052021-02-02
B086205052Protect U Guard CPE Isolation GownP105052021-02-02
B086191001Protect U Guard Hydrocolloid Sterile DressingP191002020-08-21
B086191011Protect U Guard Hydrocolloid Sterile DressingP191012020-08-21
B086191021Protect U Guard Hydrocolloid Sterile DressingP191022020-08-21
B086191031Protect U Guard Hydrocolloid Sterile DressingP191032020-08-21
B086191041Protect U Guard Hydrocolloid With Foam Backing Sterile DressingP191042020-08-21
B086191101Protect U Guard Alginate Sterile DressingP191102020-08-21
B086191111Protect U Guard Alginate Sterile DressingP191112020-08-21
B086191121Protect U Guard Alginate Sterile DressingP191122020-08-21
B086191231Protect U Guard Non-Woven DressingP191232020-08-21
B086191401Protect U Guard Flexible Fabric Adhesive BandagesP191402020-08-21

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