FDA.reportPublic FDA data

Veress insufflation needle

Primary DI
04059082013183
Brand
Veress insufflation needle
Company
SOPRO-COMEG GmbH
Model
391 027 170
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945263000OPTUS THORACOSCOPESOptus, Inc.1994-12-13GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059082013183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059082013183040590820131834059082013183

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic cannula, reusableA rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
507185952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059082002743Arthroscope161 191 040BC0012016-09-12
04059082002750Arthroscope161 240 980BC0012016-09-12
04059082002767Arthroscope161 240 982BC0012016-09-12
04059082002774Cystoscope161 271 140BC0012016-12-22
04059082002781Arthroscope161 271 190BC0012016-09-12
04059082002798Arthroscope161 271 192BC0012016-09-12
04059082002811Sinuscope161 271 760BC0012016-09-12
04059082002835Sinuscope161 271 762BC0012016-09-12
04059082002859Sinuscope161 271 765BC0012016-09-12
04059082002866Arthroscope161 271 770BC0012016-09-12
04059082002880Arthroscope161 271 772BC0012016-09-12
04059082002903Arthroscope161 271 775BC0012016-09-12
04059082002927Sinuscope161 271 780BC0012016-09-12
04059082002941Sinuscope161 271 782BC0012016-09-12
04059082002965Sinuscope161 271 785BC0012016-09-12
04059082003115Sinuscope161 401 800BC0012016-09-12
04059082003139Sinuscope161 401 802BC0012016-09-12
04059082003153Sinuscope161 401 803BC0012016-09-12
04059082003160Sinuscope161 401 805BC0012016-09-12
04059082003184Sinuscope161 401 810BC0012016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
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08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
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08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
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07613327311839Connect OR OSSTRYKER CORPORATIONGCJ2017-06-30
07613327311846Connected OR OSSTRYKER CORPORATIONGCJ2017-06-30
08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463133symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463140symphonX™Fortimedix Surgical B.V.GCJ2017-02-15