FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132800528
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-109003
Device description
HSB - Isolation Gowns Blue Level 1 - 10pack
Published
2023-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810132800689PackageGS110In Commercial Distribution
00810132800528PrimaryGS10
10810132800525Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132800689008101328006898101328006890810132800689
00810132800528008101328005288101328005280810132800528
1081013280052510810132800525

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203768304
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132800610House Brand DentistryHSB-1005612026-02-13
10810132809986House Brand DentistryHSB-1005612026-02-13
00810132808128House Brand DentistryHSB-1091202026-02-10
00810132809446House Brand DentistryHSB-4113012026-02-10
00810132808135House Brand DentistryHSB-1091202026-02-10
10810132809443House Brand DentistryHSB-4113012026-02-10
00810189432451House Brand DentistryHSB-1005742025-09-02
10810189432458House Brand DentistryHSB-1005742025-09-02
00810132800603House Brand DentistryHSB-1005602025-08-29
00810132809941House Brand DentistryHSB-1005702025-08-29
00810189432420House Brand DentistryHSB-1005712025-08-29
00810189432437House Brand DentistryHSB-1005722025-08-29
00810132809958House Brand DentistryHSB-1005602025-08-29
10810132809948House Brand DentistryHSB-1005702025-08-29
10810189432427House Brand DentistryHSB-1005712025-08-29
10810189432434House Brand DentistryHSB-1005722025-08-29
00810132802089House Brand DentistryHSB-1005332025-08-06
00810132802133House Brand DentistryHSB-1005332025-08-06
00810132808050House Brand DentistryHSB-1002352025-08-05
00810132808203House Brand DentistryHSB-1002222025-08-05

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00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
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