AccessGUDID - DEVICE: Intelliguides (G2710300260240)

GUDID

Device Identifier (DI) Information

Brand Name: Intelliguides
Version or Model: Intellifuse
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03-0026-024
Company Name: Mios Marketing, LLC

Primary DI Number: G2710300260240
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2099
Device Count: 1
Labeler D-U-N-S® Number*: 118723037 *Terms of Use

Device Description: Tibial Osteotmy Guide, 26mm x 24mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
63179	Colonic bougie	A cylindrical, rod-like, manual surgical instrument intended to be inserted into the colon to explore/assess the colonic lumen, relieve colonic spasms, or dilate strictures during open-surgery procedures. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small, bulbous tip; it may be hollow for the passing of other slender devices through it. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBF	Orthopaedic Surgical Planning And Instrument Guides

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220717	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
Length: 26 Millimeter
Depth: 24 Millimeter

Device Record Status

Public Device Record Key: 68d5ff45-ebd5-4ac8-b68e-b72b49dc13f6
Public Version Date: November 09, 2022
Public Version Number: 1
DI Record Publish Date: November 01, 2022