Duns Number:109903521
Device Description: TAP(TM)TUBING SET
Catalog Number
7205836
Brand Name
TAP
Version/Model Number
7205836
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HIF
Product Code Name
INSUFFLATOR, LAPAROSCOPIC
Public Device Record Key
c5c42184-3867-4003-9c36-cdc2bc1acdd0
Public Version Date
January 11, 2021
Public Version Number
8
DI Record Publish Date
October 05, 2015
Package DI Number
23596010463818
Quantity per Package
10
Contains DI Package
03596010463814
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |