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
00385640095167INSTRUSAFEIN-2020-77352026-10-16
00385640095082INSTRUSAFEIN-2020-82852026-10-15
00385640095099INSTRUSAFEIN-2020-81252026-10-15
00385640095105INSTRUSAFEIN-2020-82152026-10-15
00385640095112INSTRUSAFEIN-2020-79102026-10-15
00385640095129INSTRUSAFEIN-2020-82582026-10-15
00385640095136INSTRUSAFEIN-2020-80112026-10-15
00385640095143INSTRUSAFEIN-2300-05-EN-1522026-10-15
00385640095150INSTRUSAFEIN-2300-05-EN-1532026-10-15
00385640095051INSTRUSAFEIN-2020-81722026-10-14
00385640095068INSTRUSAFEIN-2020-82842026-10-14
00385640095075INSTRUSAFEIN-2020-81232026-10-14
00385640095044INSTRUSAFEIN-2020-82382026-10-13
00385640094887INSTRUSAFEIN-2020-81602026-10-09
00385640094894INSTRUSAFEIN-2020-74472026-10-09
00385640094870INSTRUSAFEIN-2020-81062026-10-08
00385640094832INSTRUSAFEIN-2020-82832026-10-07
00385640094849INSTRUSAFEIN-2020-81002026-10-07
00385640094856INSTRUSAFEIN-2020-81662026-10-07
00385640094863INSTRUSAFEIN-2020-81112026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773728067PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARDFCI S A S FCI 20 22LZU2026-10-08
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