Duns Number:040729840
Device Description: Sontec Suction Wound Retractor Illuminated 150 Millimeters X 36 Millimeters Toothed Straig Sontec Suction Wound Retractor Illuminated 150 Millimeters X 36 Millimeters Toothed Straight Edge
Catalog Number
-
Brand Name
Sontec Suction Wound Retractor
Version/Model Number
46933-06
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"
Yes
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
FGN
Product Code Name
RETRACTOR, NON-SELF-RETAINING
Public Device Record Key
a5aa6c4c-08ff-4efc-b93b-b8340fcc44f8
Public Version Date
January 29, 2021
Public Version Number
1
DI Record Publish Date
January 21, 2021
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |