Duns Number:256880576
Device Description: AMD-RITMED ALL GAUZE TRACHEOTOMY SPONGE 12 PLY 8 X 4 Inch
Catalog Number
B3010
Brand Name
AMD-RITMED ALL GAUZE
Version/Model Number
B3010
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
7f622f72-ddda-4c05-be9b-5351750b352d
Public Version Date
February 14, 2019
Public Version Number
1
DI Record Publish Date
January 14, 2019
Package DI Number
20686864053136
Quantity per Package
10
Contains DI Package
10686864053139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |