FDA.reportPublic FDA data

Medicon

Primary DI
04046826106751
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
63.11.55
Catalog number
63.11.55
Device description
Austin excavator 15cm lf
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYHEXCAVATOR, EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826106751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826106751040468261067514046826106751

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04046826486631Stern-a-Fix Sternal Closure System54.81.0854.81.082026-06-24
04046826442842Medicon Tray906.91.16906.91.162026-06-22
04046826485429MediExpand Cervical Expandable VBR System405.06.38405.06.382026-06-22
04046826485436MediExpand Cervical Expandable VBR System405.06.58405.06.582026-06-22
04046826486020Medicon Tray906.91.36906.91.362026-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060212052629Cawthorne Hook 1.5mm 90 degree blackDTR MEDICAL LIMITEDJYH2026-06-10
05060212052636Cawthorne Straight Point blackDTR MEDICAL LIMITEDJYH2026-06-10
00757770409396Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
00757770419784Bausch + LombBausch & Lomb IncorporatedJYH2025-08-18
05010058078307InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058178304InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-06-18
05010058078314InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05010058178311InstrapacROBINSON HEALTHCARE LIMITEDJYH2025-05-21
05060411986916Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
05060411986923Formby Cerumen Hook & Probe, 178mmDTR MEDICAL LIMITEDJYH2024-10-11
00887482039489Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113332Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113752Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482114216Symmetry Paparella-HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-15
00887482113684Symmetry HoughASPEN SURGICAL PRODUCTS, INC.JYH2024-08-12
09421901970895Rosen Inserter ADEPT MEDICAL LIMITEDJYH2024-04-23
09421902825224Adept Medical Cerumen Management KitADEPT MEDICAL LIMITEDJYH2024-04-19
00888515228092BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228108BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228528BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228535BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228542BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228559BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515228931BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229723BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229907BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515229914BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
00888515230248BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYH2024-02-28
G586E7214140Novo SurgicalNOVO SURGICAL, INC.JYH2023-12-18
00840343720353GEN2SURGIX MEDICAL LLCJYH2023-11-30