AccessGUDID - DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194000231)

GUDID

Device Identifier (DI) Information

Brand Name: FASSIER-DUVAL TELESCOPIC IM SYSTEM
Version or Model: T048-SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T048-SS
Company Name: Orthopediatrics Canada ULC

Primary DI Number: 07540194000231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243298854 *Terms of Use

Device Description: Tibia/Humeral Female Component for Ø4.8mm Assy

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?
44854	Arthrodesis intramedullary nail, non-distracting	A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. 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 [?]
K020885	000
K041393	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
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4.8 Millimeter

Device Record Status

Public Device Record Key: 531a39e4-ff88-4be3-82a0-ee7e7de01bb9
Public Version Date: May 13, 2025
Public Version Number: 7
DI Record Publish Date: October 20, 2016