FDA.reportPublic FDA data

PROFORMA

Primary DI
50653405051419
Brand
PROFORMA
Company
Conmed Corporation
Model
050906
Catalog number
050906
Device description
PROFORMA HF 4.5 Cannula, Straight Taper Tip
Published
2017-06-06
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
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050777000PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907Conmedcorp2005-04-22FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50653405051419PackageGS15In Commercial Distribution
40653405051412PrimaryGS10
00653405051414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5065340505141950653405051419
4065340505141240653405051412
00653405051414006534050514146534050514140653405051414

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length190Centimeter
Outer Diameter0.035Inch
Outer Diameter0.89Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature40 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
5
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24