FDA.reportPublic FDA data

NA

Primary DI
00845854024877
Brand
NA
Company
Conmed Corporation
Model
8191-01
Catalog number
8191-01
Device description
3DHD SINGLE CHANNEL STEREO ENDOSCOPE 10MM 0 DEGREE
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic video imaging system/component, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854024871Direct MarkingGS10
00845854024877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585402487120845854024871
00845854024877008458540248778458540248770845854024877

GMDN Terms#

Term, Definition table
TermDefinition
Ear lobe perforatorAn instrument used to pierce the lobe of the ear auricle (i.e., ear lobe) to create a hole in its tissue. It is typically designed as a device with a mechanism that forces a sharpened point (usually a starter earring) through the ear lobe by applying pressure to the handgrip. Although this device is primarily designed to piece the ear lobe, it can be used to pierce the ear cartilage and/or other parts of the body for, e.g., body piercing ornamentation purposes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
1
Serial number
true
Manufacturing 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
04547410480269FUJIFILMFUJIFILM CORPORATIONFET2026-05-22
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00840432200117CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04049047788553GimmiGimmi GmbHFET2026-03-04
04049047788577GimmiGimmi GmbHFET2026-03-04
04049047788584GimmiGimmi GmbHFET2026-03-04
06971176282399EviewZhuhai Pusen Medical Technology Co, LtdFET2026-01-22
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FET2025-12-31
05391533810088ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
05391533810095ProVee Video Processing UnitPROVERUM LIMITEDFET2025-12-02
04953170445538OTV-S700 UPGRADE PACK IROLYMPUS MEDICAL SYSTEMS CORP.FET2025-11-21
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04961333255801INSPIRAHOYA CORPORATIONFET2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFET2025-06-20
04250480104200NASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONFET2025-05-31
049531704302684K Camera HeadOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433313VISERA ELITE III VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170433412VISERA ELITE III LED LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04953170445453OTV-S700 UPGRADE PACK 3DOLYMPUS MEDICAL SYSTEMS CORP.FET2025-04-17
04048551432259NAKarl Storz GmbH & Co. KGFET2025-03-27
04049047788539GimmiGimmi GmbHFET2025-03-20
04049047788546GimmiGimmi GmbHFET2025-03-20
04049047788560GimmiGimmi GmbHFET2025-03-20
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.FET2025-02-28