AccessGUDID - DEVICE: canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. (00850015699078)

GUDID

Device Identifier (DI) Information

Brand Name: canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.
Version or Model: 43-5907-080-27
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Canary Medical USA LLC

Primary DI Number: 00850015699078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117153396 *Terms of Use

Device Description: Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves.

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:	No
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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QPP	Implantable Post-Surgical Kinematic Measurement Knee Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200064	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: 3bcceb02-ccb2-412d-afa6-56f1d79f8cc4
Public Version Date: April 04, 2023
Public Version Number: 2
DI Record Publish Date: September 22, 2021