FDA.reportPublic FDA data

Ritus

Primary DI
10884521811201
Brand
Ritus
Company
Mozarc Medical US LLC
Model
8817791001
Device description
Peritoneal Dialysis Accessory Blunt Tunneling Stylet
Published
2024-10-21
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
FJSCatheter, peritoneal, long-term indwelling

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521811208PackageGS15In Commercial Distribution
10884521811201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452181120820884521811208
1088452181120110884521811201

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal catheter styletA thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+39053529111RegulatoryOperations@mozarcmedical.com

Regulatory Flags#

DUNS number
118997146
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521004801MAHURKAR88137930092015-10-22
10884521004832MAHURKAR88137930132015-10-22
10884521004887MAHURKAR88138160092015-10-22
10884521004894MAHURKAR88138170052015-10-22
10884521004931MAHURKAR88156680072016-10-13
10884521005006MAHURKAR88171430052015-10-22
10884521005020MAHURKAR88171460012015-10-22
10884521005037MAHURKAR88171460072015-10-22
10884521005150MAHURKAR88304150012015-10-22
10884521005174MAHURKAR88304150032015-10-22
10884521005303MAHURKAR88325390012015-10-22
10884521005341MAHURKAR88325390062015-10-22
20884521004877MAHURKAR88138160052015-10-22
20884521005317MAHURKAR88325390022015-10-22
10884521832930MAHURKAR88156680212022-11-03
10884521832985MAHURKAR88316630212022-11-03
10884521057098MAHURKAR88156680212015-10-22
10884521057234MAHURKAR88316630212015-10-22
10884521811164Ritus88155440102026-04-20
10884521811270Ritus88108050012026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450846254Flex-Neck®Merit Medical Systems, Inc.FJS2026-07-08
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
00792079001827Faller StyletMedionics 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