Duns Number:047644935
Device Description: Lapro-Flex Finger Style Retractor 90 Degrees
Catalog Number
91680
Brand Name
Mediflex Lapro-Flex Laproscopic Instruments
Version/Model Number
91680
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
baca8a9f-3c2d-4779-b946-c1fc5f2d5364
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 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 | 882 |
2 | A medical device with a moderate to high risk that requires special controls. | 595 |