FDA.reportPublic FDA data

Rhino S

Primary DI
00865014000312
Brand
Rhino S
Company
ENDO RX LLC
Model
1
Catalog number
600001-Rhino-SW
Device description
Short Wire Compatible Biliary Catheter Device
Published
2016-11-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865014000312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865014000312008650140003128650140003120865014000312

GMDN Terms#

Term, Definition table
TermDefinition
Biliary stone retrieval balloon catheterA flexible, tubular, manual endotherapy device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) in the biliary tract. It is inserted through the working channel of an endoscope, typically beyond the stones where the balloon is inflated and retracted, the balloon pushing the trapped stones before it out of the biliary tract. It typically has more than one lumen to allow,.e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040304513
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865014000305Rhino SRD1Model 12016-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503514658Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515617Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515624Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515631Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515648Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515655Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515662Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515679Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515686Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515693Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515709Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515716Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515723Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515730Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515747Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515754Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515761Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515778Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515785Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515792Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515808Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503513873Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513880Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513897Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513903Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514627Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514634Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514641Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515310Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515327Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01