Duns Number:690625850
Device Description: The SB Knife is a single-patient use EtO-sterilized hand-held device that connects to an e
Catalog Number
-
Brand Name
SB Knife /Jr type - Long
Version/Model Number
MD-47703L
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
KNS
Product Code Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Public Device Record Key
0e54a692-f6fb-4e2a-b9d1-509b06894c43
Public Version Date
May 30, 2022
Public Version Number
7
DI Record Publish Date
September 12, 2016
Package DI Number
24545499064671
Quantity per Package
1
Contains DI Package
04545499064677
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |