FDA.reportPublic FDA data

Q-3500 Eclipse Ti-130

Primary DI
00814005024905
Brand
Q-3500 Eclipse Ti-130
Company
Quality Aspirators, Inc.
Model
Q-3500 Eclipse Ti-130
Catalog number
308-10030
Device description
Q-3500 Eclipse Ti-130
Published
2025-02-27
Public version status
New
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
00814005024905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005024905008140050249058140050249050814005024905

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
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
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
00814005023304M-2.5 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023311M-2.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023328M-3.0 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023335M-3.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023342M-3.5 FlipQuality Aspirators, Inc.HJH2025-02-27
00814005023359M-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023458P-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023465P-4.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023472P-4.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005023496Prism Combo CaseQuality Aspirators, Inc.HJH2025-02-27
00814005023502Q877Quality Aspirators, Inc.HJH2025-02-27
00814005023519Q879Quality Aspirators, Inc.HJH2025-02-27
00814005024196F-3.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024219EP-3.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024226EP-4.0 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024233EP-4.5 TTLQuality Aspirators, Inc.HJH2025-02-27
00814005024240Q-Optics Loupe CaseQuality Aspirators, Inc.HJH2025-02-27
00814005024318SVRXQuality Aspirators, Inc.HJH2025-02-27
00814005024325BRXQuality Aspirators, Inc.HJH2025-02-27
00814005024332Q-Optics Loupe and Light Combo CaseQuality Aspirators, Inc.HJH2025-02-27
00814005024530FILTER 5151Quality Aspirators, Inc.HJH2025-02-27
00814005024561Eclipse TiQuality Aspirators, Inc.HJH2025-02-27
00814005024578Eclipse-QDNPQuality Aspirators, Inc.HJH2025-02-27
00814005024608FILTER 5801Quality Aspirators, Inc.HJH2025-02-27
00814005024615FILTER PI11Quality Aspirators, Inc.HJH2025-02-27
00814005024622FILTER PI4Quality Aspirators, Inc.HJH2025-02-27
00814005024639FILTER PN10Quality Aspirators, Inc.HJH2025-02-27
00814005024691Side Shield for Q877Quality Aspirators, Inc.HJH2025-02-27
00814005024707Side Shield for Q879Quality Aspirators, Inc.HJH2025-02-27
00814005024769Strap 1Quality Aspirators, Inc.HJH2025-02-27