Duns Number:005036025
Device Description: The Midmark 630 Gynecology Debris Tray is intended to be larger and deeper than the averag The Midmark 630 Gynecology Debris Tray is intended to be larger and deeper than the average debris tray for use with gynecological exams and procedures.
Catalog Number
9A555001
Brand Name
Midmark
Version/Model Number
9A555001
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
GBB
Product Code Name
CHAIR, SURGICAL, AC-POWERED
Public Device Record Key
ccae2bda-84e1-4860-87c8-ecdcaf06448a
Public Version Date
October 29, 2020
Public Version Number
1
DI Record Publish Date
October 21, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |