FDA.reportPublic FDA data

TREU

Primary DI
04048447333929
Brand
TREU
Company
TREU-Instrumente GmbH
Model
8-09771
Catalog number
8-09771
Device description
Steinmann Pin 2,8 x228mm trocar point triangular shaft
Published
2018-06-13
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
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083912000TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINSTreu-Instrumente GmbH2009-07-15HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048447333929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048447333929040484473339294048447333929

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679476730info@treu.com

Regulatory Flags#

DUNS number
341154493
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048447018437TREU7-13907-13902018-06-13
04048447028153TREU8-11148-11142018-06-13
04048447028160TREU8-11168-11162018-06-13
04048447028177TREU8-11188-11182018-06-13
04048447028757TREU8-12708-12702016-10-17
04048447028900TREU8-12248-12242016-10-17
04048447045587TREU8-099318-099312018-06-13
04048447206230TREU7-14417-14412018-06-13
04048447219117TREU7-14027-14022018-06-13
04048447257676TREU7-14457-14452018-06-13
04048447257867TREU8-125408-125402016-10-27
04048447285822TREU99-8130699-813062016-10-17
04048447299478TREU8-13020-18-13020-12016-10-17
04048447333813TREU7-13927-13922018-06-13
04048447333820TREU7-13947-13942018-06-13
04048447333837TREU7-14037-14032018-06-13
04048447333844TREU7-14217-14212018-06-13
04048447333851TREU7-14057-14052018-06-13
04048447333868TREU7-14077-14072018-06-13
04048447333875TREU8-113028-113022018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052990971893DOLPHIXCITIEFFE SRLJDW2024-10-28
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08905892004674GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004681GPCGPC MEDICAL LIMITEDJDW2024-01-31
08905892004698GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004742GPCGPC MEDICAL LIMITEDJDW2024-01-31
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08905892004568GPCGPC MEDICAL LIMITEDJDW2023-12-30
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08720629950556ANSER Clavicle PinBaat Medical Products B.V.JDW2022-12-14
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