Duns Number:832696038
Device Description: RIGHT ANGLE DISSECTOR SINGLE-PIECE, DOUBLE ACTION 37CM, 5MM INSUL SHFT, ROT, NON-RATCHETED
Catalog Number
88-8315
Brand Name
Snowden-Pencer
Version/Model Number
88-8315
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
-
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
K925114
Product Code
HFI
Product Code Name
COAGULATOR, CULDOSCOPIC (AND ACCESSORIES)
Public Device Record Key
b114ec67-52c1-4f07-ad43-cc02b61cba12
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 23, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |