Duns Number:832696038
Device Description: SCISSORS INSERT, CVD METZ 45CM, 10/BOX
Catalog Number
SP8401
Brand Name
Snowden-Pencer
Version/Model Number
SP8401
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
8312b763-cdda-4957-8c25-eca632f853cb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 17, 2017
Package DI Number
20885403184144
Quantity per Package
10
Contains DI Package
10885403184147
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |