Duns Number:315304071
Device Description: INSUFFLATION TUBE SET L 2.7M with integrated hygiene filter, PVC, PACK=10 PCS, sterile, f INSUFFLATION TUBE SET L 2.7M with integrated hygiene filter, PVC, PACK=10 PCS, sterile, for single use
Catalog Number
4170.501
Brand Name
NA
Version/Model Number
4170501
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)
-
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
6cdb4448-57ea-4ce1-ab60-1f53e3dc8762
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
June 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |