Duns Number:927071162
Device Description: TO3 - Laparoscopic smoke evacuation tube with Flow Restrictor (1 each/ 12 pcs per Case)
Catalog Number
-
Brand Name
MediMax Tech
Version/Model Number
TO3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
-
Product Code
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
778f8ed9-74d4-4085-aad2-b0e3fe206d71
Public Version Date
November 24, 2020
Public Version Number
1
DI Record Publish Date
November 16, 2020
Package DI Number
10817325023822
Quantity per Package
12
Contains DI Package
00817325023825
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |