Duns Number:832696038
Device Description: Snowden-Pencer MIS DIAMOND-LINE GRASPER CROCODILE, DOUBLE-ACTION 5MM, 36CM, RATCHETED ESU Snowden-Pencer MIS DIAMOND-LINE GRASPER CROCODILE, DOUBLE-ACTION 5MM, 36CM, RATCHETED ESU PAT PENDING
Catalog Number
SP90-6366
Brand Name
Snowden-Pencer
Version/Model Number
SP90-6366
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
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
36503f3c-c26c-4278-99a6-ee5e47c5b4b1
Public Version Date
March 31, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |