AccessGUDID - DEVICE: FASSIER-DUVAL TELESCOPIC IM SYSTEM (07540194006721)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 07540194006721
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243298854 *Terms of Use

Device Description: TAPERED BURR

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?
64295	Metal-cutting bur	A rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTT	BURR, ORTHOPEDIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: fff75755-4003-4f58-a810-d184ddeac556
Public Version Date: May 13, 2025
Public Version Number: 4
DI Record Publish Date: May 06, 2020