Duns Number:015272206
Device Description: Penfield MIS dissector, 10 5/8'', size #2, bayonet shaft, curved up 2.0mm, push model, rou Penfield MIS dissector, 10 5/8'', size #2, bayonet shaft, curved up 2.0mm, push model, round handle
Catalog Number
44-261
Brand Name
Ambler Surgical
Version/Model Number
Penfield MIS dissector
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
GDI
Product Code Name
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
a85e1a83-cdb9-4470-8ee5-4ee0b19b6057
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |