FDA.reportPublic FDA data

Faller Stylet

Primary DI
00792079001827
Brand
Faller Stylet
Company
Medionics International Inc
Model
FS-404
Catalog number
FS-404
Published
2026-02-02
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
FJSCatheter, Peritoneal, Long-Term Indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJSCatheter, Peritoneal, Long-Term IndwellingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130441000FALLER STYLETMedionics International, Inc.2013-04-19FJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792079001827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792079001827007920790018277920790018270792079001827

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-472-6544info@medionics.com

Regulatory Flags#

DUNS number
241421320
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792079000639Peritoneal Dialysis CatheterCA-2272CA-22722026-02-02
00792079000752Peritoneal Dialysis Catheter AdapterPCA-1010PCA-10102026-02-02
00792079000424Faller StyletFS-401FS-4012018-04-09
00792079001216Faller StyletFS-402FS-4022018-04-09
00792079001223Faller StyletFS-403FS-4032018-04-09
00792079000431StyletSST-650SST-6502018-04-09
00792079000028Peritoneal Dialysis CatheterSA-1247SA-12472018-04-09
00792079000035Peritoneal Dialysis CatheterSA-1248KSA-1248K2018-04-09
00792079000141Peritoneal Dialysis CatheterSI-1231SI-12312015-09-17
00792079000196Peritoneal Dialysis CatheterCA-2262CA-22622015-09-17
00792079000219Peritoneal Dialysis CatheterCA-1162CA-11622015-09-17
00792079000226Peritoneal Dialysis CatheterCA-1157CA-11572018-04-09
00792079000264Peritoneal Dialysis CatheterCP-1241CP-12412015-09-17
00792079000356Peritoneal Dialysis CatheterSNCA-5262LSNCA-5262L2015-09-17
00792079000363Peritoneal Dialysis CatheterSNCP-5243LSNCP-5243L2015-09-17
00792079000394Peritoneal Dialysis Catheter AdapterTA-200TA-2002018-04-09
00792079000400Peritoneal Dialysis Catheter AdapterTA-300TA-3002018-04-09
00792079000592Peritoneal Dialysis CatheterSNPS-53113SNPS-531132015-09-17
00792079000967Peritoneal Dialysis CatheterSNCA-5263LFDSNCA-5263LFD2018-04-09
00792079001476Peritoneal Dialysis CatheterPSNA-100PSNA-1002015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450104484Flex-Neck®Merit Medical Systems, Inc.FJS2026-04-21
00884450773314Flex-Neck®Merit Medical Systems, Inc.FJS2026-04-21
10884521811270RitusMozarc Medical US LLCFJS2026-04-20
10884521852822ArgyleMozarc Medical US LLCFJS2026-02-06
00792079000639Peritoneal Dialysis CatheterMedionics International IncFJS2026-02-02
00792079000752Peritoneal Dialysis Catheter AdapterMedionics International IncFJS2026-02-02
00884450104682Flex-Neck®Merit Medical Systems, Inc.FJS2025-12-03
10884450104689Flex-Neck®Merit Medical Systems, Inc.FJS2025-12-03
10884521852891RitusMozarc Medical US LLCFJS2025-11-27
10884521811102RitusMozarc Medical US LLCFJS2025-11-27
10884521852631RitusMozarc Medical US LLCFJS2025-11-27
10884521852648RitusMozarc Medical US LLCFJS2025-11-27
10884521852686RitusMozarc Medical US LLCFJS2025-11-27
10884521852693RitusMozarc Medical US LLCFJS2025-11-27
10884521852709RitusMozarc Medical US LLCFJS2025-11-27
10884521852730RitusMozarc Medical US LLCFJS2025-11-27
10884521852747RitusMozarc Medical US LLCFJS2025-11-27
10884521852754RitusMozarc Medical US LLCFJS2025-11-27
10884521852761RitusMozarc Medical US LLCFJS2025-11-27
10884521852792RitusMozarc Medical US LLCFJS2025-11-27
10884521852808RitusMozarc Medical US LLCFJS2025-11-27
10884521852846RitusMozarc Medical US LLCFJS2025-11-27
10884521852853RitusMozarc Medical US LLCFJS2025-11-27
10884521852860RitusMozarc Medical US LLCFJS2025-11-27
10884521852877RitusMozarc Medical US LLCFJS2025-11-27
10884521852884RitusMozarc Medical US LLCFJS2025-11-27
20884521852898RitusMozarc Medical US LLCFJS2025-11-27
10884521852907RitusMozarc Medical US LLCFJS2025-11-27
10884521852938RitusMozarc Medical US LLCFJS2025-11-27
10884521852945RitusMozarc Medical US LLCFJS2025-11-27