FDA.reportPublic FDA data

MONDEAL

Primary DI
04050435096808
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-06508
Catalog number
27-06508
Device description
Screws- and K-Wire Measuring plate M4
Published
2017-06-26
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
04050435096808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050435096808040504350968084050435096808

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. This is a single-use device.

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
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
04050435118654MONDEAL26-5081426-508142020-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17