Duns Number:117308190
Device Description: 5mm tip length, 3cm shaft length
Catalog Number
SST-N
Brand Name
Sp-Tip
Version/Model Number
SST-N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K183611,K183611
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
b1c61401-8a86-4c4b-9288-1d2800b589dc
Public Version Date
April 12, 2021
Public Version Number
2
DI Record Publish Date
January 18, 2021
Package DI Number
00810026182037
Quantity per Package
2
Contains DI Package
00810026181061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 124 |