Duns Number:832696038
Device Description: ANDREW BABCOCK GRASPER SINGLE-PIECE, DOUBLE ACTION 45CM, 5MM, 19MM JAW INSUL SHFT, ROT, RA ANDREW BABCOCK GRASPER SINGLE-PIECE, DOUBLE ACTION 45CM, 5MM, 19MM JAW INSUL SHFT, ROT, RATCHETED
Catalog Number
88-8308
Brand Name
Snowden-Pencer
Version/Model Number
88-8308
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
K925079
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
bf2303c0-a39f-4da8-83d2-cafdb94303d6
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 |