Duns Number:063519193
Device Description: Assemble n' Go Faceshield Replacement Lenses, Use With TIDI Products Dispenser Holder 7001
Catalog Number
9211-400
Brand Name
TIDI
Version/Model Number
9211-400
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
6889b042-65d3-43b9-971d-348c24cd7f62
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
10618125132659
Quantity per Package
4
Contains DI Package
00618125132652
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |