Duns Number:247326606
Device Description: SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless stee SoftFil® Precision are sterile and single use injection kits containing:- 1 stainless steel pre-hole needle in its protective cap,- 1 stainless steel, graduated blunt-tip needle (micro-cannula) 16G x 90 mm in its protective cap.
Catalog Number
-
Brand Name
SoftFil® Precision
Version/Model Number
CP1690U
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
-
Product Code
GEA
Product Code Name
Cannula, Surgical, General & Plastic Surgery
Public Device Record Key
e89c5ef5-bb81-4e4e-820b-9b809b95ac43
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 2022
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 | 8 |
| 3 | A medical device with high risk that requires premarket approval | 1 |