FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
10810189432427
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-100571
Device description
HSB - CSR Wrap 15 x 15 - 100/Sheets
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810189432420PrimaryGS10
10810189432427Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189432420008101894324208101894324200810189432420
1081018943242710810189432427

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
203768304
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
00810132808067House Brand DentistryHSB-1002352025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013676PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013683PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014888PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014895PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014901PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015014PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015021PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015038PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015045PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015090PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015106PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013003PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013027PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013034PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013041PRIMEDpriMED Medical Products IncFRG2026-05-29