FDA.reportPublic FDA data

4.5mm/3.5mm LCP Metaphyseal Plate

Primary DI
EMAH20002247560
Brand
4.5mm/3.5mm LCP Metaphyseal Plate
Company
mahe medical gmbh
Model
200-0224-756
Catalog number
200-0224-756
Device description
4.5mm/3.5mm LCP Metaphyseal Plate
Published
2016-08-04
Public version status
Update
Distribution status
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
EMAH20002247561PackageHIBCC1In Commercial Distribution
EMAH20002247560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length170Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00cool, dry & dark place
Storage Environment Humidity10 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius28 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+49(0)746592750info@mahe-med.de

Regulatory Flags#

DUNS number
342243334
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMAHKM714590Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unitKM71-459KM71-4592016-06-13
EMAHKM715100Steinmann pin w. trocar/round end 2.0mm/229mm, 6 pcs./unitKM71-510KM71-5102016-04-28
EMAHKM715130Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unitKM71-513KM71-5132016-04-28
EMAHKM718800Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur PasserKM71-880KM71-8802016-06-10
04050659210974mahe medical GmbH004-800092019-11-05
04050659484832mahe medical GmbHKM71-4592019-11-05
04050659484948mahe medical GmbHKM71-5102019-11-05
04050659484955mahe medical GmbHKM71-5132019-11-05
04050659485228mahe medical GmbHKM71-6752019-11-05
04050659485600mahe medical GmbHKM71-8802019-11-05
EMAHCHM01100Set screw w.plate f.polyaxial screwsCHM01-10CHM01-102016-07-05
EMAHCHM01110Set screw f.polyaxial screwsCHM01-11CHM01-112016-07-05
EMAHPSR1175450Polyaxial screw reduct., w/o cannulation 7.5mm/45mmPSR11-7545PSR11-75452016-08-04
EMAHPSR1175500Polyaxial screw reduct., w/o cannulation 7.5mm/50mmPSR11-7550PSR11-75502016-08-04
EMAHPSR1175550Polyaxial screw reduct., w/o cannulation 7.5mm/55mmPSR11-7555PSR11-75552016-08-04
EMAHPSR1175600Polyaxial screw reduct., w/o cannulation 7.5mm/60mmPSR11-7560PSR11-75602016-08-04
EMAHPSS0845250Polyaxial screw, w/o cannulation, 4.5mm/25mmPSS08-4525PSS08-45252016-07-05
EMAHPSS0845300Polyaxial screw, w/o cannulation, 4.5mm/30mmPSS08-4530PSS08-45302016-07-06
EMAHPSS0845350Polyaxial screw, w/o cannulation, 4.5mm/35mmPSS08-4535PSS08-45352016-07-06
EMAHPSS0845400Polyaxial screw, w/o cannulation, 4.5mm/40mmPSS08-4540PSS08-45402016-07-06

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