FDA.reportPublic FDA data

Loupe and Combo Case Name Plate

Primary DI
00814005024806
Brand
Loupe and Combo Case Name Plate
Company
Quality Aspirators, Inc.
Model
Loupe and Combo Case Name Plate
Catalog number
308-10097
Device description
Loupe and Combo Case Name Plate
Published
2025-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
HJHLoupe, binocular, low power

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814005024806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005024806008140050248068140050248060814005024806

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
121431159
Device count
1
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
00814005020006TATA300-100002025-02-27
0081400502001315P2-90A15P2-90A300-100012025-02-27
0081400502003703BAT03BAT300-100032025-02-27
0081400502005115P3A15P3A300-100062025-02-27
0081400502006803BA03BA300-100072025-02-27
0081400502008202BA02BA300-100092025-02-27
0081400502009946P3M46P3M300-100102025-02-27
0081400502010515P2AT15P2AT300-100112025-02-27
0081400502013615P2A15P2A300-100142025-02-27
00814005020143FR3FR3300-100152025-02-27
00814005020174FR15P2FR15P2300-100182025-02-27
00814005020181FR2FR2300-100192025-02-27
00814005020198FR4FR4300-100202025-02-27
0081400502020446P3AT46P3AT300-100212025-02-27
0081400502021115P2-1/415P2-1/4300-100222025-02-27
0081400502022815P3-1/415P3-1/4300-100232025-02-27
0081400502023556P256P2300-100242025-02-27
0081400502024256P356P3300-100252025-02-27
0081400502026615P3HO15P3HO300-100272025-02-27
0081400502027315P3AT15P3AT300-100292025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095540106zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540113zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540120zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540410zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540427zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540434zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540441zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540458zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540465zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540472zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540489zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540496zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540502zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540519zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540526zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540533zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540540zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540557zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540564zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540571zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540588zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540595zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540601zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540618zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540625zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540632zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540649zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540656zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540663zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540670zumaxZumax Medical Co., LTDHJH2026-05-18