Duns Number:328485453
Device Description: Insulated Tube 5 mm
Catalog Number
L-IT05
Brand Name
Vitalitec
Version/Model Number
L-IT05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
K944270
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
e8a7c494-9323-4778-a8f5-502f62b2b736
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 12, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 228 |