Duns Number:421340711
Catalog Number
-
Brand Name
Peng’s Multifunctional Operative Dissector(PMOD)
Version/Model Number
IIIA-D006-SG039
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040780,K040780,K040780
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
243a14e2-7d63-4926-9239-090dd0a31686
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
06924274955917
Quantity per Package
25
Contains DI Package
06924274955900
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 171 |