FDA.reportPublic FDA data

Medicon

Primary DI
04046826317614
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
63.68.10
Catalog number
63.68.10
Device description
HM burr w dental shank 1.0mm p/10
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046826108847PrimaryGS10
04046826317614Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826108847040468261088474046826108847
04046826317614040468263176144046826317614

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
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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Primary DI, Brand, Company table
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00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
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10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
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07613327652710PROstepSTRYKER CORPORATIONHWE2026-04-13
07613327652727N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652734N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25