Duns Number:006133784
Device Description: SofTIP Guide Cannula
Catalog Number
FG-0008
Brand Name
SofTIP
Version/Model Number
60-02
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
K090385,K090385,K090385,K090385
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
c154e4bc-2669-415b-81d0-a4cd6d01eb03
Public Version Date
January 19, 2021
Public Version Number
1
DI Record Publish Date
January 11, 2021
Package DI Number
30840143901809
Quantity per Package
1
Contains DI Package
10840143901812
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |
| 3 | A medical device with high risk that requires premarket approval | 11 |