Duns Number:063519193
Device Description: DRAPE, BLUE ELASTICIZED TIP VIDEO CAMERA BOX OF 25
Catalog Number
-
Brand Name
TIDI
Version/Model Number
5433
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
KQM
Product Code Name
Camera, Surgical And Accessories
Public Device Record Key
dc465502-9dbd-401b-9b6e-19bd9dbe80d4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 2017
Package DI Number
00618125142231
Quantity per Package
25
Contains DI Package
01618125142230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |