FDA.reportPublic FDA data

Comfortear™

Primary DI
10810003223583
Brand
Comfortear™
Company
MICROSPECIALITIES, INC.
Model
24-2004
Catalog number
24-2004
Device description
Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Pedi, 0.5mm.
Published
2019-01-03
Public version status
Update
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
K050851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050851000DELTA PUNCTUM PLUGDelta Life Science, Inc.2005-08-19LZU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30810003223587PackageGS12In Commercial Distribution
10810003223583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081000322358730810003223587
1081000322358310810003223583

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
203-874-1832xx@xx.xx

Regulatory Flags#

DUNS number
013469890
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810003224757NAMK8510LSKMK8510LSK2026-04-29
10810003224764NAMK8511CB2026-04-29
10810003224771NA3001352026-04-29
10810003224788NA3001602026-04-29
10810003224795NA300202026-04-29
10810003224801NAMK85072026-04-29
10810003224818NAMK85082026-04-29
10810003223545Comfortear™24-200824-20082019-01-03
10810003223552Comfortear™24-200724-20072019-01-03
10810003223569Comfortear™24-200624-20062019-01-03
10810003223576Comfortear™24-200524-20052019-01-03
10810003223590Comfortear™32-200832-20082019-01-03
10810003223606Comfortear™32-200732-20072019-01-03
10810003223613Comfortear™32-200632-20062019-01-03
10810003223620Comfortear™32-200532-20052019-01-03
10810003223637Comfortear™32-200432-20042019-01-03
10810003223644Comfortear™60-601060-60102019-01-03
10810003224443Pro-Paks1002PL1002PL2023-09-02
10810003224450Pro-Paks2002PL2002PL2023-09-02
10810003224467Pro-PaksES BasicES Basic2023-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640072403Quintess®Summit Medical, Inc.LZU2026-05-13
00385640072410Quintess®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
00810061911968SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911975SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911982SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911913SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911920SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12