FDA.reportPublic FDA data

ARROW

Primary DI
10801902170184
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN917306
Catalog number
CC-01700
Device description
Laparoscopic Cholangiography Balloon Catheter
Published
2021-09-22
Public version status
Update
Distribution status
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
GBZCATHETER, CHOLANGIOGRAPHY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902170181PackageGS15In Commercial Distribution
10801902170184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190217018120801902170181
1080190217018410801902170184

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801902003362ARROWTELEFLEX INCORPORATEDGBZ2026-08-03
14026704742452TAUTTELEFLEX INCORPORATEDGBZ2026-08-01
00810158211872PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
00810158211889PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
00733132657902GORE TIPS SetW. L. Gore & Associates, Inc.GBZ2024-07-15
14026704924353TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924360TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924377TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924384TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924421TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
14026704924438TAUTTELEFLEX INCORPORATEDGBZ2024-06-19
G587MAS0070PRINCETONPrinceton Medical Group, Inc.GBZ2023-12-14
04049197181631Guyon Catheters RZ-Medizintechnik GmbHGBZ2023-08-16
04049197264310Metal CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197264440Metal catheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466059FOLEY CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466080Rotunda KatheterRZ-Medizintechnik GmbHGBZ2023-08-16
B80291000american catheter CORPAmerican Catheter Corp.GBZ2023-06-20
00827002217652COOKCOOK INCORPORATEDGBZ2022-12-08
00827002218680COOKCOOK INCORPORATEDGBZ2022-12-08
00827002220300COOKCOOK INCORPORATEDGBZ2022-12-08
00827002315907COOKCOOK INCORPORATEDGBZ2022-12-08
14026704742438TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742445TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742469TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742476TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742483TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742506TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
14026704742513TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
24026704742435TAUTTELEFLEX INCORPORATEDGBZ2022-09-23