FDA.reportPublic FDA data

Medicon

Primary DI
04046826317676
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
63.68.23
Catalog number
63.68.23
Device description
HM burr w dental shank 2.3mm 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
04046826108908PrimaryGS10
04046826317676Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046826108908040468261089084046826108908
04046826317676040468263176764046826317676

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00193982616472ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
00193982616489ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
03701089527897AMPLITUDEAMPLITUDE SASHWE2026-07-29
03701089542326AMPLITUDEAMPLITUDE SASHWE2026-07-29
00841731153135ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153142ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153159ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153166ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
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04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
00842078125724CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09