FDA.reportPublic FDA data

Medicon

Primary DI
04046826108656
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
63.65.94
Catalog number
63.65.94
Device description
Larkin hand trephine 15cm Ø 0.8mm
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
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826108656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826108656040468261086564046826108656

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery burA small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes of various shapes on one end, designed to excavate soft tissue or cartilage during general and/or plastic surgery. It is usually power-driven by a rotary handpiece or other powered device. 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
04046826002572Medicon03.05.1703.05.172026-04-30
04046826020507Medicon14.06.1214.06.122026-04-30
04046826023331Medicon15.70.1415.70.142026-04-30
04046826023362Medicon15.71.1415.71.142026-04-30
04046826050849Medicon47.30.1347.30.132026-04-30
04046826063764Medicon51.99.5051.99.502017-05-31
04046826032807Medicon24.26.1224.26.122026-04-13
04046826531508Medicon68.94.70A68.94.70A2026-04-02
04046826531522Medicon68.94.72A68.94.72A2026-04-02
04046826531539Medicon68.94.76A68.94.76A2026-04-02
04046826531515Medicon68.94.71A68.94.71A2026-04-01
04046826416942Medicon68.93.51A68.93.51A2026-03-25
04046826541385Medicon68.93.4268.93.422026-03-25
04046826495930Medicon Tray906.91.86906.91.862026-03-24
04046826495985Medicon Tray906.91.33906.91.332026-03-24
04046826447953Medicon Tray906.91.25906.91.252026-03-24
04046826495923Medicon Tray906.91.86906.91.862026-03-24
04046826495978Medicon Tray906.91.33906.91.332026-03-24
04046826445928Medicon Tray906.91.22906.91.222026-03-20
04046826445935Medicon Tray906.91.23906.91.232026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
20757770457568Bausch + LombBausch & Lomb IncorporatedJYO2026-04-30
20757770457551Bausch + LombBausch & Lomb IncorporatedJYO2026-04-29
09348811150233INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-04-10
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811108869INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811108913INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109040INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109057INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109064INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109071INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109088INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109095INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109170INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109187INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811149909INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26