Duns Number:878427491
Device Description: Mahalik Posterior Glenoid Retractor with Long Handle
Catalog Number
1909
Brand Name
Innomed, Inc.
Version/Model Number
1909
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
1bc2e50f-e5a7-40f7-8a47-fb295bfa4bac
Public Version Date
April 17, 2020
Public Version Number
1
DI Record Publish Date
April 09, 2020
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 | 2683 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |