FDA.reportPublic FDA data

Quintess®

Primary DI
00385640072410
Brand
Quintess®
Company
Summit Medical, Inc.
Model
1658
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZUPlug, Punctum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030300000OPAQUE HERRICK LACRIMAL PLUGLacrimedics, Inc.2003-05-09LZU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00385640072410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00385640072410003856400724103856400724100385640072410

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal punctum plugA sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
888-229-2875CustomerService@innoviamedical.com

Regulatory Flags#

DUNS number
965484699
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385640092166INSTRUSAFEIN-2020-73682026-08-07
00385640092173INSTRUSAFEIN-2020-76952026-08-07
00385640092180INSTRUSAFEIN-2020-77622026-08-07
00385640092197INSTRUSAFEIN-2020-79202026-08-07
00385640092203INSTRUSAFEIN-2020-78342026-08-07
00385640092210INSTRUSAFEIN-2020-77452026-08-07
00385640092227INSTRUSAFEIN-2020-79362026-08-07
00385640092234INSTRUSAFEIN-2020-79372026-08-07
00385640092241INSTRUSAFEIN-2020-77682026-08-07
00385640092258INSTRUSAFEIN-2020-77302026-08-07
00385640092265INSTRUSAFEIN-2020-77342026-08-07
00385640092272INSTRUSAFEIN-2020-72702026-08-07
00385640092289INSTRUSAFEIN-2020-78352026-08-07
00385640092296INSTRUSAFEIN-2020-76522026-08-07
00385640092302INSTRUSAFEIN-2020-76772026-08-07
00385640092319INSTRUSAFEIN-2600-10-EN-0102026-08-07
00385640092326INSTRUSAFEIN-2020-76752026-08-07
00385640092333INSTRUSAFEIN-2600-08-EN-0142026-08-07
00385640092340INSTRUSAFEIN-2020-78102026-08-07
00385640092357INSTRUSAFEIN-3030-02792026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773731906TearSaver® - 0.4 mmFCI S A S FCI 20 22LZU2026-07-09
13700773731913TearSaver® - 0.5 mmFCI S A S FCI 20 22LZU2026-07-09
13700773736994TearSaver® - 0.8 mmFCI S A S FCI 20 22LZU2026-07-09
13700773737007Snug plugFCI S A S FCI 20 22LZU2026-07-09
23700773728705PRELOADED PERFORATED PLUG PVP - J.A. BERNARDFCI S A S FCI 20 22LZU2026-07-09
23700773728712PRELOADED MINI PERFORATED PLUG PVP - J.A. BERNARDFCI S A S FCI 20 22LZU2026-07-09
00385640072403Quintess®Summit Medical, Inc.LZU2026-05-13
00385640089562Summit MedicalSummit Medical, Inc.LZU2025-12-29
00385640089579Summit MedicalSummit Medical, Inc.LZU2025-12-29
00840277405098Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405104Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405111Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405128Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405095Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405101Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405118Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405125Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
08800024300009Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300016Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300672Hello, eyesBio Optics Co., LtdLZU2024-07-30
00810061911197SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911203SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911210SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911227SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911234SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911241SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911258SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911265SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911944SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911951SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12