Duns Number:627969264
Device Description: Insufflation general use tubing set for use with the Nebulae I laparoscopic insufflator
Catalog Number
-
Brand Name
Insufflation Tubing, Laparoscopic
Version/Model Number
7-510-52
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
HIF
Product Code Name
Insufflator, Laparoscopic
Public Device Record Key
4473081c-9a20-41e7-89e4-38468cd27246
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
10817183020223
Quantity per Package
10
Contains DI Package
00817183020226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |