Duns Number:109903521
Device Description: FLUID SEALS, FOR USE WITH 72200026, BOX OF 25
Catalog Number
72200027
Brand Name
INTELIJET
Version/Model Number
72200027
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
-
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
FEI
Product Code Name
INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
Public Device Record Key
28260ae2-8b92-41da-b5b8-3eae3d35458a
Public Version Date
October 07, 2020
Public Version Number
5
DI Record Publish Date
August 29, 2015
Package DI Number
23596010543992
Quantity per Package
25
Contains DI Package
03596010543998
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |