FDA.reportPublic FDA data

LacriCATH

Primary DI
10634624810195
Brand
LacriCATH
Company
QUEST MEDICAL INC
Model
LDC315T
Device description
LacriCATH Lacrimal Duct Balloon Catheter, 3 mm.
Published
2016-10-14
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
OKSLacrimal Stents And Intubation Sets

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKSLacrimal Stents And Intubation SetsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113867000LACRICATH LACRIMAL DUCT CATHETERQuest Medical, Inc.2012-10-19OKS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624783151PackageGS12In Commercial Distribution
10634624810195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063462478315120634624783151
1063462481019510634624810195

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, single-useA sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-627-0226Custserv@questmedical.com

Regulatory Flags#

DUNS number
041810693
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
00634624530485MPS® 3 Console Pole Mount Plate530102453010242026-07-20
006346240906516" (15 cm) Microbore Extension Set with Clamp90652017-02-13
006346240925017 in (18cm) Y-Extension Set w/ 2 check valves925092502016-07-26
0063462409541044 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site954195412016-07-26
00634624095434Q2 Checkmate Extension Set95432016-06-10
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621077Precision Delivery IV Extension SetPDV062021-02-05
00634624621084Precision Delivery IV Extension SetPDV06F2021-02-05
00634624621091Precision Delivery IV Extension SetPDV602021-02-05
00634624621107Precision Delivery IV Extension SetPDV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET FCI S A S FCI 20 22OKS2026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732088STOPLOSS® JONES TUBE 4 X 14 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732095STOPLOSS® JONES TUBE 4 X 15 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732101STOPLOSS® JONES TUBE 4 X 16 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732118STOPLOSS® JONES TUBE 4 X 17 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732125STOPLOSS® JONES TUBE 4 X 18 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732132STOPLOSS® JONES TUBE 4 X 19 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732149STOPLOSS® JONES TUBE 4 X 20 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732156STOPLOSS® JONES TUBE 4 X 21 MM FCI S A S FCI 20 22OKS2026-04-20
13700773732163STOPLOSS® JONES TUBE 4 X 22 MM FCI S A S FCI 20 22OKS2026-04-20
13700773735072STOPLOSS® JONES TUBE REMOVAL TOOL FCI S A S FCI 20 22OKS2026-04-20