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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic
LQRDislodger, Stone, Biliary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
LQRDislodger, Stone, BiliaryGastroenterology, 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
Lot or batch
true
Expiration date on label
true

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
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00850078427311ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427328ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427335ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427342ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427359ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427366ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427373ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
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00850078427397ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427403ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427410ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427427ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427434ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427441ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427458ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427465ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427472ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427489ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
15711055003237M-DrainMermaid Medical A/SFGE2026-09-04
15711055003244M-DrainMermaid Medical A/SFGE2026-09-04
04052838002417Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
04052838002431Endoflux™Medi-Globe GmbHFGE2026-08-27