FDA.report

MONDEAL

Primary DI
04050435040580
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-03919
Catalog number
27-03919
Device description
Reamer 19 mm konvex AO
Published
2017-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050435040580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050435040580040504350405804050435040580

GMDN Terms

TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497463993070mail@mondeal.de
+1904-641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags

DUNS number
312546955
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050435135255MONDEAL27-0650027-065002021-07-07
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04050435135279MONDEAL27-0650227-065022021-07-07
04050435135286MONDEAL27-0650727-065072021-07-07
04050435135293MONDEAL27-0650827-065082021-07-07
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04050435040511MONDEAL27-0374927-037492020-10-21
04050435040528MONDEAL27-0377327-037732020-10-21
04050435040535MONDEAL27-0379827-037982020-10-21
04050435069185MONDEAL27-0373227-037322020-10-21
04050435069192MONDEAL27-0376427-037642020-10-21
04050435069208MONDEAL27-0378527-037852020-10-21
04050435113758MONDEAL26-5071626-507162020-10-21
04050435113772MONDEAL26-5072026-507202020-10-21
04050435113789MONDEAL26-5072226-507222020-10-21
04050435114564MONDEAL26-5071426-507142020-10-21
04050435114939MONDEAL26-5072426-507242020-10-21
04050435118630MONDEAL26-5072626-507262020-10-21
04050435118647MONDEAL26-5072826-507282020-10-21

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