Duns Number:832696038
Device Description: Snowden-Pencer SLIDELOCK GRASPER MODULAR, SINGLE ACTION 45 CM, 5MM, 22MM JAW RETRACT, INSU Snowden-Pencer SLIDELOCK GRASPER MODULAR, SINGLE ACTION 45 CM, 5MM, 22MM JAW RETRACT, INSUL SHFT, ROT, RACH
Catalog Number
88-8203
Brand Name
Snowden-Pencer
Version/Model Number
88-8203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 05, 2020
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
K925079
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
ac9ab06b-07d6-4fec-85e5-665c7c5fc647
Public Version Date
March 04, 2022
Public Version Number
6
DI Record Publish Date
September 23, 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 |