FDA.reportPublic FDA data

MONDEAL

Primary DI
04050435040535
Brand
MONDEAL
Company
MONDEAL Medical Systems GmbH
Model
27-03798
Catalog number
27-03798
Device description
8-hole Compression Fibula-Plate M3 green
Published
2020-10-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050435040535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050435040535040504350405354050435040535

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is 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
DM exempt
true
Lot or batch
true
Manufacturing date on label
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
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
08809986482600CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482617CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482624CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482631CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482648CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482655CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482662CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482679CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482686CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482792CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482808CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482877CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482884CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482891CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482907CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482914CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482921CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482952CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482969CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482976CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482983CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482990CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483027CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483034CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483041CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599169TriLEAPSynthes GmbHHRS2025-03-18