Duns Number:109903521
Device Description: FEMORAL CANAL SUCTION ABSORBER STANDARD 19MM DIAMETER
Catalog Number
110037
Brand Name
NA
Version/Model Number
110037
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
K831999,K831999
Product Code
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
2921b59b-8701-42dd-8fb2-b1273ffcbbbb
Public Version Date
February 17, 2022
Public Version Number
4
DI Record Publish Date
September 21, 2015
Package DI Number
23596010033325
Quantity per Package
6
Contains DI Package
03596010033321
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 |