FDA.reportPublic FDA data

NA

Primary DI
00816765011942
Brand
NA
Company
US Endoscopy
Model
00712031
Catalog number
00712031
Device description
Ponsky Guidewire Cholangiography System Round Tip
Published
2016-09-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCACATHETER, BILIARY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765011949PackageGS15Not in Commercial Distribution
00816765011942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501194910816765011949
00816765011942008167650119428167650119420816765011942

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, non-balloon, non-electrical, single-useA non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length68Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)769-8226global@usendoscopy.com

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910757NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910709NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910716NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910747NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910754NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
00191506013493SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
00191506013509SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
00191506013516SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
10195594641436CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
50195594641434CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
10827002588032AdvanceCOOK INCORPORATEDGCA2021-02-09
10827002588049AdvanceCOOK INCORPORATEDGCA2021-02-09
00690103205114FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205121FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205138FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205119FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205126FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205133FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00816349011696TaxiLake Region MedicalGCA2018-11-27
04711182607548Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2017-08-15