FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
10653405045755
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD4GKM
Catalog number
CD4GKM
Device description
10mm Gasket, Replacement Part, Reusable
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
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBMCannula and trocar, suprapubic, non-disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950457000CANNUAL AND TROCAR, SUPERPUBICCore Dynamics, Inc.1995-05-05HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405045755PackageGS15In Commercial Distribution
20653405045752PrimaryGS10
00653405045758Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340504575510653405045755
2065340504575220653405045752
00653405045758006534050457586534050457580653405045758

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, single-useA sterile, rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31
20653405990939GENESYS™ CrossFT™CFBC-5503RCFBC-5503R2026-07-31
20653405990946GENESYS™ CrossFT™CFBC-6502RCFBC-6502R2026-07-31
20653405990953GENESYS™ CrossFT™CFBC-6503RCFBC-6503R2026-07-31
10653405000242YANKAUER003447000344702016-09-24
10845854035559E9000E9015E90152026-03-24
20653405008559CONMED60-0824-00160-0824-0012016-09-24
30653405003230CONMED1380111380112016-09-24
30653405003247CONMED1380121380122016-09-24
30653405058230AER DEFENSE60-8084-00160-8084-0012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653405045007CORE DYNAMICSConmed CorporationFBM2026-03-24
10653405045021CORE DYNAMICSConmed CorporationFBM2026-03-24
10653405045038CORE DYNAMICSConmed CorporationFBM2026-03-24
10653405045069CORE DYNAMICSConmed CorporationFBM2026-03-24
10653405045083CORE DYNAMICSConmed CorporationFBM2026-03-24
10653405045090CORE DYNAMICSConmed CorporationFBM2026-03-24
08403207004482Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004499Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004505Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004512Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004529Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004536Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004543Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
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00842962109052HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
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00842962109076HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109083HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109090HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
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00842962109113HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109021HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109038HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109045HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842331178023Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-14
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