Duns Number:175899459
Device Description: Versaport Plus V2 RT 11 mm Obturator with 5 mm Plus Seal 3/bx
Catalog Number
AUT179102P-3
Brand Name
NA
Version/Model Number
AUT179102P-3
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"
Yes
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
K012578
Product Code
NLM
Product Code Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
Public Device Record Key
bb71eab6-98ee-4a5e-9eb8-e5f8608c9c5d
Public Version Date
August 14, 2019
Public Version Number
4
DI Record Publish Date
September 22, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |