Trice Tablet 2 - Tablet for use with mi-eye 2 probe - TRICE MEDICAL, INC.

Duns Number:009452895

Device Description: Tablet for use with mi-eye 2 probe

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More Product Details

Catalog Number

-

Brand Name

Trice Tablet 2

Version/Model Number

T200-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162475

Product Code Details

Product Code

HRX

Product Code Name

Arthroscope

Device Record Status

Public Device Record Key

6e2974f9-b099-46f1-9772-35c6e00a7765

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRICE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 7