FDA.reportPublic FDA data

Natura

Primary DI
00877972005810
Brand
Natura
Company
GENICON, INC.
Model
210-112-151
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982472000GENICON TROCARGenicon, LC1999-02-04GEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00877972005810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00877972005810008779720058108779720058100877972005810

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079805400
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00877972006718X-Surge590-005-0132019-11-14
00877972001980GeniSurge533-005-9052017-05-05
00877972001997GeniSurge533-005-9102017-05-05
00877972002000GeniSurge533-005-9152017-05-05
00877972002017GeniSurge533-005-9202017-05-05
00877972002154GeniSurge533-005-9252017-05-05
00877972002161GeniSurge533-005-9302017-05-05
00877972002178GeniSurge533-005-9352017-05-05
00877972002185GeniSurge533-005-9402017-05-05
00877972002192GeniSurge533-005-9452017-05-05
00877972002208GeniSurge533-005-9502017-05-05
00877972004615GeniSurge533-105-9102017-05-05
00877972005957NanoSurge528-063-9102017-05-05
00877972005971NanoSurge528-063-9202017-05-05
00877972005995NanoSurge528-063-9452017-05-05
00877972006015NanoSurge528-063-9502017-05-05
00877972006190NanoSurge520-063-9102017-05-05
00877972006213NanoSurge520-063-9202017-05-05
00877972006237NanoSurge520-063-9452017-05-05
00877972006251NanoSurge520-063-9502017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130456901Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456918Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456925Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456932Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456949Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456956Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456963Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456970Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456987Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130456994Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457007Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457014Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457021Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457038Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457045Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457052Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457069Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457076Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457083Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457106Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457113Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457120Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457137Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457144Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457168Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457175Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457182Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457212Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457229Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23
00810130457236Medco ManufacturingMedco Manufacturing LLCGEA2026-10-23