FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132803550
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-300246
Device description
HSB - Mathieu Needle Holder 5.5'' Elastomeric
Published
2024-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810132803550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132803550008101328035508101328035500810132803550

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203768304
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4250601180My MedicalMy Medical Store LLCHTD2026-05-04
G4250601350My MedicalMy Medical Store LLCHTD2026-05-04
G4250602970My MedicalMy Medical Store LLCHTD2026-05-04
G4250602980My MedicalMy Medical Store LLCHTD2026-05-04
G425310840NC0My MedicalMy Medical Store LLCHTD2026-05-04
G4254402140My MedicalMy Medical Store LLCHTD2026-05-04
G4254403120My MedicalMy Medical Store LLCHTD2026-05-04
G8142900SFPP3Garish ApparelsGARISH APPARELSHTD2026-04-28
09348811015402INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-21
09348811012678INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012722INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811012913INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811013163INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811014603INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
09348811129345INKAThe Trustee for KAISER FAMILY TRUSTHTD2025-11-19
10649111493270Trinity Sterile, Inc.SKLAR CORPORATIONHTD2024-12-12
G586UR6201390Novo SurgicalNOVO SURGICAL, INC.HTD2024-07-23
10195327656256Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-07-10
10195327621100Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HTD2024-02-05
G508RSCMD4700Raw Surgical CorporationRAW SURGICAL CORPORATIONHTD2023-11-19
G1413040800Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040820Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G1413040840Carnegie Surgical LLCCarnegie Surgical LLCHTD2023-04-08
G25003003120Halsted Mosquito Forceps 12.5cm StraightN S SURGICAL COMPANYHTD2023-01-31
G25003004120Halsted Mosquito Forceps 12.5cm CurvedN S SURGICAL COMPANYHTD2023-01-31
G25003051180Standard Tube Forceps 18cmN S SURGICAL COMPANYHTD2023-01-30
G25003052180Foerster Sponge Forceps 18cm StraightN S SURGICAL COMPANYHTD2023-01-30
G25003001100Hartmann Mosquito Forcep 10cm StraightN S SURGICAL COMPANYHTD2023-01-28
G25003002100Hartmann Mosquito Forcep 10cm CurvedN S SURGICAL COMPANYHTD2023-01-28
G25003007120Micro Mosquito Forceps 12cm StraightN S SURGICAL COMPANYHTD2023-01-28