TI 3.5mm mono-/polyaxial locking screw, L.38mm

Basic Information

• Brand Name: TI 3.5mm mono-/polyaxial locking screw, L.38mm
• Primary DI: EMAH1506635038PTXL0
• Version / Model: 150-6635-038PTXL
• Catalog Number: 150-6635-038PTXL
• Company Name: mahe medical gmbh
• Labeler DUNS: 342243334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-02
• Public Version: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 0aa90559-f646-4275-94d5-20902ddf3b9e

Device Description

TI 3.5mm mono-/polyaxial locking screw, L.38mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56642	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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EMAH1506635038PTXL1	HIBCC		1	In Commercial Distribution
Primary	EMAH1506635038PTXL0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	38.0	Millimeter
Outer Diameter	3.5	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 28 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 50 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: cool, dry & dark place