FDA.reportPublic FDA data

MONDEAL

Primary DI
04050435135255
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-06500
Catalog number
27-06500
Device description
Depth comparison instrument for K-Wire 150 mm, M1 / M2 200 mm
Published
2021-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050435135255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050435135255040504351352554050435135255

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
312546955
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050435040702MONDEAL27-0804027-080402017-06-26
04050435040771MONDEAL27-0806027-080602017-06-26
04050435041112MONDEAL27-0833027-083302017-06-26
04050435135286MONDEAL27-0650727-065072021-07-07
04050435135293MONDEAL27-0650827-065082021-07-07
04050435096792MONDEAL27-0650727-065072017-06-26
04050435096808MONDEAL27-0650827-065082017-06-26
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 DI, Brand, Company table
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