FDA.reportPublic FDA data

"Bouffant Cap 21"" Blue"

Primary DI
00850037747238
Brand
"Bouffant Cap 21"" Blue"
Company
Safesource Direct, L.L.C.
Model
BHC30021BE
Device description
"Blue Bouffant Cap 21"" outside diameter."
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10850037747235PackageGS14In Commercial Distribution
00850037747238PrimaryGS10
20850037747232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003774723510850037747235
00850037747238008500377472388500377472380850037747238
2085003774723220850037747232

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA 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 may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
3372107920general@safesourcedirect.com

Regulatory Flags#

DUNS number
118070602
Device count
100
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
00850037747467Extra Large Blue Shoe CoverSC30022024-10-10
00850037747474Universal Shoe Cover Super TreadSC30032024-10-10
00850037747481Extra Large Extra Traction Shoe CoverSC30042024-10-10
10850037747464Extra Large Blue Shoe CoverSC30022024-10-10
10850037747471Universal Shoe Cover Super TreadSC30032024-10-10
10850037747488Extra Large Extra Traction Shoe CoverSC30042024-10-10
00850037747221"Bouffant Cap 21"" White"BHC30021WE2024-10-01
00850037747245"Bouffant Cap 24"" White"BHC30024WE2024-10-01
00850037747252"Bouffant Cap 24"" Blue"BHC30024BE2024-10-01
10850037747228Bouffant Cap 21" WhiteBHC30021WE2024-10-01
10850037747235Bouffant Cap 21" BlueBHC30021BE2024-10-01
10850037747242Bouffant Cap 24" WhiteBHC30024WE2024-10-01
10850037747259Bouffant Cap 24" BlueBHC30024BE2024-10-01
00850037747382Plant Based Procedural MaskPM3003-W-ECO2024-04-05
00850037747122SafeSource Direct Level 1 Surgical Mask with TiesSM30012023-05-16
00850037747139SafeSource Direct Level 3 Surgical Mask with TiesSM30032023-05-16
00850037747146SafeSource Direct Level 1 Procedure Mask with Ear LoopsPM30012023-05-16
00850037747269SafeSource Shoe CoversSC30012023-05-16
00850037747153SafeSource Direct Level 3 Procedure Mask with Ear LoopsPM30032023-05-16

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