FDA.reportPublic FDA data

Surgyco

Primary DI
10850053289795
Brand
Surgyco
Company
Surgyco LLC
Model
STF00710
Device description
FOLEY CATHETER 2 WAYS, 3CC 10FR SILICONE COATED
Published
2024-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082815000WELL LEAD SILICONE AND LATEX FOLEY CATHETERSWell Lead Medical Instruments2008-10-08EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850053289792PackageGS1500In Commercial Distribution
10850053289795PrimaryGS10
00850053289798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085005328979220850053289792
1085005328979510850053289795
00850053289798008500532897988500532897980850053289798

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Regulatory Flags#

DUNS number
118768538
Device count
10
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
10850074089060Surgyco010-VPSB21G22025-12-23
10850074089077Surgyco010-VPSB23G22025-12-23
10850074089084Surgyco010-VPSB25G22025-12-23
10850074089091Surgyco010-VPB23G22025-12-23
10850074089107Surgyco010-VPN01102025-12-23
10850074089114Surgyco010-VPN01202025-12-23
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
10850053289672SurgycoSEN102302025-12-11
20850053289679SurgycoSEN102302025-12-11
10850074089053ClinicoLab010-16622025-09-10
10850053289870SURGYCOSSNG00102025-07-11
10850053289887SURGYCOSSNG00152025-07-11
10850053289894SURGYCOSSNG00202025-07-11
10850074089015JDL Sensitive010-12502025-07-11
10850074089022JDL Sensitive010-12602025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04