AccessGUDID - DEVICE: TriLeap Lower Extremity Anatomic Plating System (00810112592986)

GUDID

Device Identifier (DI) Information

Brand Name: TriLeap Lower Extremity Anatomic Plating System
Version or Model: 2.0 mm Ti Cortex Screw Length 22 mm, Blue
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04.901.022
Company Name: CROSSROADS EXTREMITY SYSTEMS

Primary DI Number: 00810112592986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058864308 *Terms of Use

Device Description: 2.0 mm Ti Cortex Screw Length 22 mm, Blue

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230591	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3526c2d-ca22-4eeb-ac90-39a44c77ab06
Public Version Date: March 01, 2024
Public Version Number: 2
DI Record Publish Date: February 22, 2024