FDA.reportPublic FDA data

Protect U Guard Doctor Cap Blue

Primary DI
B086203012
Brand
Protect U Guard Doctor Cap Blue
Company
PROTECT U GUARD, LLC
Model
P20301
Published
2017-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B086203012PrimaryHIBCC0
B086203010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA non-sterile head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080070945
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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
B086191241Protect U Guard Non-Woven DressingP291242020-08-21
B086191401Protect U Guard Flexible Fabric Adhesive BandagesP191402020-08-21

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