Duns Number:047644935
Device Description: Mediflex P/N: 91683-A Lapro-Flex Retractor - 80mm Angled Triangle Base, 5mm
Catalog Number
-
Brand Name
Mediflex Lapro-Flex Laproscopic Instruments
Version/Model Number
38015
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
b75e12a7-3683-4004-a7a9-36edad3fc4e2
Public Version Date
May 23, 2019
Public Version Number
1
DI Record Publish Date
May 15, 2019
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 | 882 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |