FDA.reportPublic FDA data

RIVOS™

Primary DI
00191506062620
Brand
RIVOS™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00553900
Catalog number
M00553900
Device description
EUS Access Device
Published
2026-06-25
Public version status
New
Distribution status
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
KNSUnit, electrosurgical, endoscopic (with or without accessories)
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506062620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506062620001915060626201915060626200191506062620

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Regulatory Flags#

DUNS number
021717889
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
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17