FDA.reportPublic FDA data

Medicon

Primary DI
04046826110222
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
66.10.21
Catalog number
66.10.21
Device description
universal holder f Ø 2.7-10mm
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYKHOLDER, EAR SPECULUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYKHolder, Ear SpeculumGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826110222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826110222040468261102224046826110222

GMDN Terms#

Term, Definition table
TermDefinition
ENT speculum holderA device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags#

DUNS number
315492330
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046826047443Medicon44.90.7244.90.722026-07-31
04046826380830Medicon Tray906.90.57906.90.572026-07-30
04046826380939Medicon Tray906.90.76906.90.762026-07-30
04046826413187Medicon Tray906.92.05906.92.052026-07-30
04046826413194Medicon Tray906.92.06906.92.062026-07-30
04046826413200Medicon Tray906.92.08906.92.082026-07-30
04046826438180Medicon Tray906.92.18906.92.182026-07-30
04046826495800Medicon Tray906.91.32906.91.322026-07-30
04046826495954Medicon Tray906.91.87906.91.872026-07-30
04046826486228Medicon68.85.23A68.85.23A2026-07-29
04046826531478Medicon68.85.21A68.85.21A2026-07-29
04046826531485Medicon68.85.22A68.85.22A2026-07-29
04046826561741Medicon68.93.04A68.93.04A2026-07-29
04046826531454Medicon68.85.19A68.85.19A2026-07-28
04046826110833Medicon66.27.5366.27.532026-07-21
04046826346812Medicon68.86.89A68.86.89A2026-06-25
04046826416676Medicon68.87.28A68.87.28A2026-06-25
04046826542337Medicon68.86.4868.86.482026-06-25
04046826543655Medicon68.86.4968.86.492026-06-25
04046826552473Medicon68.93.4168.93.412026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275761Intrace USAPILOTIS TECH LLCJYK2026-07-03
04250676730015MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730022MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730039MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676730046MENTIO disposable ear speculaSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676734884MENTIO disposable cerumen hookSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
04250676746634MENTIO disposable ear curette/cottonSpiggle & Theis Medizintechnik GmbHJYK2025-10-07
00840183527402BR Surgical, LLCBR Surgical, LLCJYK2024-11-26
G043606200BEARBear-Ent, LLCJYK2023-03-06
G043606220BEARBear-Ent, LLCJYK2023-03-06
G043606230BEARBear-Ent, LLCJYK2023-03-06
G043606280BEARBear-Ent, LLCJYK2022-06-01
B351GC03800mytaMedMytamed, Inc.JYK2021-02-11
B351BGC03800BEARMytamed, Inc.JYK2021-01-18
B351BMN1699V0BEARMytamed, Inc.JYK2021-01-18
04046826101787MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYK2020-09-24
10381780084648Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYK2018-10-24
24026704526745PILLINGTELEFLEX INCORPORATEDJYK2018-09-15
00821925011663Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
00821925011670GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011687GYRUS ACMI, INCGyrus ACMI, LLCJYK2018-09-07
00821925011694Gyrus ACMIGyrus ACMI, LLCJYK2018-09-07
10381780110866MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110873MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110897MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110910MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12
10381780110835MicroFrance®INTEGRA MICROFRANCEJYK2018-01-12