Duns Number:256880576
Device Description: AMD-RITMED DISSECTOR SPONGE X-RAY DETECTABLE 3/8 X 1/4 Inch
Catalog Number
1757H
Brand Name
AMD-RITMED
Version/Model Number
1757H
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
c110b865-924e-4b9e-84e6-5251d2e06525
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
Package DI Number
20686864046220
Quantity per Package
100
Contains DI Package
10686864046223
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 |