FDA.report

mahe medical GmbH

Primary DI
04050659465619
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
HBS-1003-12S
Device description
TI HBS self-drilling high compression _x000D_screw,cannulated,12mm _x000D_Ø3.2/2.5mm
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050659465619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050659465619040506594656194050659465619

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050659161702mahe medical GmbH001-0001-006S2019-11-05
04050659161719mahe medical GmbH001-0001-006ST2019-11-05
04050659161726mahe medical GmbH001-0001-006XS2019-11-05
04050659161740mahe medical GmbH001-0001-007S2019-11-05
04050659161757mahe medical GmbH001-0001-007ST2019-11-05
04050659161764mahe medical GmbH001-0001-007XS2019-11-05
04050659161801mahe medical GmbH001-0001-008XS2019-11-05
04050659161825mahe medical GmbH001-0001-009S2019-11-05
04050659161849mahe medical GmbH001-0001-009XS2019-11-05
04050659161863mahe medical GmbH001-0001-010S2019-11-05
04050659161887mahe medical GmbH001-0001-010XS2019-11-05
04050659161948mahe medical GmbH001-0001-012S2019-11-05
04050659161962mahe medical GmbH001-0001-012XS2019-11-05
04050659162013mahe medical GmbH001-0001-014S2019-11-05
04050659162037mahe medical GmbH001-0001-014XS2019-11-05
04050659162051mahe medical GmbH001-0001-016S2019-11-05
04050659162068mahe medical GmbH001-0001-016ST2019-11-05
04050659162075mahe medical GmbH001-0001-016XS2019-11-05
04050659162112mahe medical GmbH001-0001-018XS2019-11-05
04050659162150mahe medical GmbH001-0001-020XS2019-11-05

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