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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Regulatory Flags#

DUNS number
121431159
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814005025650Q-OpticsDFV Nike Skylon Adapter with Small T-Slot2026-07-02
00814005025667Q-OpticsDFV Nike Skylon Adapter2026-07-02
00814005025674Q-OpticsM-SUDOVETAIL Assembly2026-07-02
00814005025681Quality AspiratorsPFO2026-07-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06945095542032zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542049zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542056zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542063zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542070zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542087zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542094zumaxZumax Medical Co., LTDHJH2026-06-03