Duns Number:076907973
Device Description: Sponge Counter Rack. Holds a dispenser box of sponge counter bags as well as displays 4 b Sponge Counter Rack. Holds a dispenser box of sponge counter bags as well as displays 4 bags for use counting sponges during surgery. Clamps to a 1" pole. .
Catalog Number
MCM262
Brand Name
NA
Version/Model Number
MCM262
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
FOX
Product Code Name
Stand, Infusion
Public Device Record Key
419d46c8-bc95-446c-9df3-e417cf4ae43b
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 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 | 342 |