FDA.reportPublic FDA data

CORE DYNAMICS

Primary DI
20653405044960
Brand
CORE DYNAMICS
Company
Conmed Corporation
Model
CD155
Catalog number
CD155
Device description
5.5mm Sealing Cap
Published
2016-09-24
Public version status
Update
Distribution status
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
K911813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911813000ENTREE CANNULACore Dynamics, Inc.1991-07-19FBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405044963PackageGS110In Commercial Distribution
20653405044960PrimaryGS10
00653405044966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340504496310653405044963
2065340504496020653405044960
00653405044966006534050449666534050449660653405044966

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal reducer, single-useA small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.

Device Sizes#

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

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
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
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10653405045090CORE DYNAMICSConmed CorporationFBM2026-03-24
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08403207004536Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004543Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
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