FDA.reportPublic FDA data

Jagtome™ Pro RX 44

Primary DI
00191506039288
Brand
Jagtome™ Pro RX 44
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00584440
Catalog number
M00584440
Device description
Sphincterotome
Published
2023-10-25
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506039288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506039288001915060392881915060392880191506039288

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, electrosurgicalA flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

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
00191506004583WATCHMAN FLX™ ProM635WU60200M635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProM635WU60240M635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProM635WU60270M635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProM635WU60310M635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProM635WU60350M635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProM635WU60400M635WU604002023-09-12
08714729195573RotaWire™ and wireClip™ TorquerH802232390010H8022323900102014-09-24
08714729195566RotaWire™ and wireClip™ TorquerH802228240020H8022282400202014-09-24
08714729837527Stingray™H749M3004A02016-09-24
08714729877523EP XT™M0042007720M00420077202016-09-24
08714729877714Dynamic XT™M0042011120M00420111202016-09-24
08714729879947EP XT™M0046EPXT00390M0046EPXT003902016-09-24
08714729181088Percuflex™ BiliaryM005337602015-09-24
08714729181095Percuflex™ BiliaryM005337702015-09-24
08714729181101Percuflex™ BiliaryM005337802015-09-24
08714729181118Percuflex™ BiliaryM005337902015-09-24
08714729181125Percuflex™ BiliaryM005338002015-09-24
08714729181132Percuflex™ BiliaryM005338102015-09-24
08714729181149Percuflex™ BiliaryM005338202015-09-24
08714729181156Percuflex™ BiliaryM005338302015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503512227Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-08
16932503512210Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512234Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512241Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512258Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512265Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512272Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512289Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512296Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512302Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512319Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512326Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512333Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512340Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512357Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512364Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512371Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512388Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512395Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512401Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512418Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513187Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513194Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513200Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
14953170466349Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
14953170466356Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
00827002613508SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613512SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613529SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002607842COOKCOOK INCORPORATEDKNS2025-07-22