FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
20653405045882
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD6300P
Catalog number
CD6300P
Device description
Trocar Procedure Kit
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10653405045885PackageGS110Not in Commercial Distribution
20653405045882PrimaryGS10
00653405045888Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340504588510653405045885
2065340504588220653405045882
00653405045888006534050458886534050458880653405045888

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

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
10
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24

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
00842962130278HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130285HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130292HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130308HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130315HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962109052HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109069HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109076HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109083HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109090HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109106HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
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
00842331150944Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-12