FDA.reportPublic FDA data

Surgimedics®

Primary DI
10814716020002
Brand
Surgimedics®
Company
COASTAL LIFE TECHNOLOGIES, INC.
Model
908010-000
Device description
Cholangiography Catheter
Published
2017-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
10814716020002PackageGS15In Commercial Distribution
00814716020005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081471602000210814716020002
00814716020005008147160200058147160200050814716020005

GMDN Terms#

Term, Definition table
TermDefinition
Cholangiopancreatography catheter, single-useA 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); this is a diagnostic-therapeutic procedure that involves the x-ray of the ducts after introduction of a contrast material. 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809254670
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
10814716020866NA905114-REL2016-09-23
00814716020012Surgimedics®9050212016-09-23
00814716020029Surgimedics®9050182016-09-23
00814716020036Surgimedics®9050192016-09-23
00814716020043Surgimedics®9050602016-09-23
00814716020364Surgimedics®9050122016-09-23
00814716020494Surgimedics®9050252016-09-23
00814716020500Surgimedics®9050262016-09-23
00814716020517Surgimedics®9010252016-09-23
00814716020548Surgimedics®9020342016-09-23
00814716020555Surgimedics®9020372016-09-23
00814716020562Surgimedics®9050462016-09-23
00814716020579Surgimedics®9050482016-09-23
00814716020586Surgimedics®9050512016-09-23
00814716020593Surgimedics®9050612016-09-23
00814716020609Surgimedics®9050622016-09-23
00814716020616Surgimedics®9050452016-09-23
00814716020623Surgimedics®9010152016-09-23
00814716020630Surgimedics®9050112016-09-23
00814716020647Surgimedics®9050802016-09-23

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