FDA.reportPublic FDA data

Cortical screws (1.25mm), 3.5x34mm cannulated, self cutting

Primary DI
EMAH0010004034CS0
Brand
Cortical screws (1.25mm), 3.5x34mm cannulated, self cutting
Company
mahe medical gmbh
Model
001-0004-034CS
Catalog number
001-0004-034CS
Device description
Cortical screws (1.25mm), 3.5x34mm cannulated, self cutting
Published
2016-07-28
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
HWCScrew, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMAH0010004034CS1PackageHIBCC1In Commercial Distribution
EMAH0010004034CS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterile"A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression. This device must be sterilized prior to use."

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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