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
10801902167344ARROWIPN916986CA-22123-F2026-07-30
10801902190908ARROWIPN919754CC-04100-S2026-07-30
10801902192933ARROWIPN920077CDA-25122-U1A2026-07-30
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902193527ARROWIPN920130CS-15242-SPM2026-07-30
10801902193619ARROWIPN920140CS-15232-VFIM2026-07-30
10801902193626ARROWIPN920141CS-15232-VF2026-07-30
10801902193633ARROWIPN920142CS-15232-VFM2026-07-30
10801902193688ARROWIPN920131CS-15282-SPM2026-07-30
10801902194463ARROWIPN920404CS-15232-VFI2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30
10801902197716ARROWIPN920778JC-05400-E2026-07-30
10801902198461ARROWIPN920836PW-18080-HN2026-07-30
10801902200768ARROWIPN921145CL-078352026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
24026704742442TAUTTELEFLEX INCORPORATEDGBZ2022-09-23
24026704742466TAUTTELEFLEX INCORPORATEDGBZ2022-09-23