FDA.reportPublic FDA data

F-3.0 TTL

Primary DI
00814005024196
Brand
F-3.0 TTL
Company
QUALITY ASPIRATORS, INC.
Model
F-3.0 TTL
Catalog number
308-10077
Device description
F-3.0 TTL
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
00814005024196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005024196008140050241968140050241960814005024196

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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06945095556022zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556039zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556046zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556053zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556060zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556077zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556084zumaxZumax Medical Co., LTDHJH2026-07-06
06945095556091zumaxZumax Medical Co., LTDHJH2026-07-06
06945095541110zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541424zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541448zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541929zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541936zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541943zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541950zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541967zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541974zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541981zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541998zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542001zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542018zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542025zumaxZumax Medical Co., LTDHJH2026-06-03
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