FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
20653405046247
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD8400
Catalog number
CD8400
Device description
CORE Trumpet
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
GBWCATHETER, PERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405046247PackageGS120In Commercial Distribution
10653405046240PrimaryGS10
00653405046243Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340504624720653405046247
1065340504624010653405046240
00653405046243006534050462436534050462430653405046243

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

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
20
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
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50749756035755DeRoyalDEROYAL INDUSTRIES, INC.GBW2023-03-03
20801902197942ARROWTELEFLEX INCORPORATEDGBW2022-11-09
10653405050032CORE DYNAMICSConmed CorporationGBW2022-06-02
04710961935865Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935872Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935889Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935896Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935902Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605810Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605827Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04711182605759Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-12-15
04710961935858Silicone Sump Drain TubeFORTUNE MEDICAL INSTRUMENT CORP.GBW2021-11-24
14543527251959Super Sheath CBDETOGO MEDIKIT CO.,LTD.GBW2021-05-14
M368395310GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953120GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953140GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953340GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
M3683953580GrafcoGF HEALTH PRODUCTS, INC.GBW2021-05-10
00827002026254CookCOOK INCORPORATEDGBW2020-10-02
00827002043855CookCOOK INCORPORATEDGBW2020-10-02
00827002052673CookCOOK INCORPORATEDGBW2020-10-02
00827002052680CookCOOK INCORPORATEDGBW2020-10-02
20801902162926ARROWTELEFLEX INCORPORATEDGBW2020-04-28
34026704656456TAUTTELEFLEX INCORPORATEDGBW2019-06-03
24026704656466TAUTTELEFLEX INCORPORATEDGBW2019-06-03
34026704656470TAUTTELEFLEX INCORPORATEDGBW2019-06-03
00801902005243ARROWTELEFLEX INCORPORATEDGBW2019-03-07
34026704656487TAUTTELEFLEX INCORPORATEDGBW2019-02-28
20801902121725ARROWTELEFLEX INCORPORATEDGBW2018-10-25