FDA.reportPublic FDA data

EXAMINE

Primary DI
20653405037566
Brand
EXAMINE
Company
Conmed Corporation
Model
PCC01
Catalog number
PCC01
Device description
Percutaneous Cholangiography Catheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921921000CATHETER CHOLANGIOGRAPHYLaparomed Corp.1992-08-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405037566PackageGS110In Commercial Distribution
10653405037569PrimaryGS10
30653405037563PrimaryGS10
00653405037562Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503756620653405037566
1065340503756910653405037569
3065340503756330653405037563
00653405037562006534050375626534050375620653405037562

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
10
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
true

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30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
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10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
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10653405013785THERMOGARD7-3847-3842016-09-24
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30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
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