AccessGUDID - DEVICE: mi-eye 2 160mm (00861578000362)

GUDID

Device Identifier (DI) Information

Brand Name: mi-eye 2 160mm
Version or Model: T200-160
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TRICE MEDICAL, INC.

Primary DI Number: 00861578000362
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 009452895 *Terms of Use

Device Description: mi-eye 2 probe 160mm length for use with Trice Tablet 2

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?
62570	Rigid optical arthroscope, single-use	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structural damage to a joint, often from sports injuries. The eyepiece is normally interfaced with a video camera. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	Arthroscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162475	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 95 Millimeter

Device Record Status

Public Device Record Key: 79d3e934-d3a3-43f6-87ea-50a917a70b88
Public Version Date: March 03, 2025
Public Version Number: 5
DI Record Publish Date: September 20, 2017