FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
20653405046308
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD8450
Catalog number
CD8450
Device description
For Single or Dual Solution Bags
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
20653405046308PackageGS120In Commercial Distribution
10653405046301PrimaryGS10
00653405046304Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340504630820653405046308
1065340504630110653405046301
00653405046304006534050463046534050463040653405046304

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.

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
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
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10653405050032CORE DYNAMICSConmed CorporationGBW2022-06-02
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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