AccessGUDID - DEVICE: ODI Talon™ Intramedullary Hip Nail (B058THN125380L1)

GUDID

Device Identifier (DI) Information

Brand Name: ODI Talon™ Intramedullary Hip Nail
Version or Model: THN125380L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orthopedic Designs North America, Inc.

Primary DI Number: B058THN125380L1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 945518848 *Terms of Use

Device Description: Proximal Femoral Nail, 125 Degrees - 380mm Long: Left (11mm Distal Diameter)

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?
33187	Femur nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033286	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
Device Size Text, specify: Left
Angle: 125 degree
Length: 380 Millimeter
Outer Diameter: 11 Millimeter

Device Record Status

Public Device Record Key: 0791e105-c93b-4edb-b8ba-f63f3633a8d1
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 22, 2015