FDA.reportPublic FDA data

FILTER PI11

Primary DI
00814005024615
Brand
FILTER PI11
Company
Quality Aspirators, Inc.
Model
FILTER PI11
Catalog number
308-10089
Device description
FILTER PI11
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
00814005024615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005024615008140050246158140050246150814005024615

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06945095541950zumaxZumax Medical Co., LTDHJH2026-06-03
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06945095544722zumaxZumax Medical Co., LTDHJH2026-06-03
06945095548096zumaxZumax Medical Co., LTDHJH2026-06-03