FDA.report

MONDEAL

Primary DI
04050435041129
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-08340
Catalog number
27-08340
Device description
Plate Cutting Forceps M3
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
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050435041129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050435041129040504350411294050435041129

GMDN Terms

TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
04050435135262MONDEAL27-0650127-065012021-07-07
04050435135279MONDEAL27-0650227-065022021-07-07
04050435135286MONDEAL27-0650727-065072021-07-07
04050435135293MONDEAL27-0650827-065082021-07-07
04050435135309MONDEAL27-0803427-080342021-07-07
04050435135316MONDEAL27-0803627-080362021-07-07
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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Primary DIBrandCompanyProduct codePublished
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00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
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00840180544662General InstrumentsALPHATEC SPINE, INC.HTZ2025-12-31
10603295553663ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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10603295553694ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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