Duns Number:832696038
Device Description: Snowden-Pencer MIS ERGONOMIC TAKE-APART IN-LINE MAYFIELD FLIP NEEDLE HOLDER ROTATING, RATC Snowden-Pencer MIS ERGONOMIC TAKE-APART IN-LINE MAYFIELD FLIP NEEDLE HOLDER ROTATING, RATCHETED HANDLE 5MM, 45CM, COMPLETE INSTRUMENT
Catalog Number
SP96-8427
Brand Name
Snowden-Pencer
Version/Model Number
SP96-8427
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 05, 2021
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
00c248e8-97d7-459f-98b7-c3ff9b015e6e
Public Version Date
March 09, 2022
Public Version Number
5
DI Record Publish Date
September 28, 2017
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 |