Duns Number:256880576
Device Description: 4 IN x 100 FT STERILIZATION REEL
Catalog Number
A94100
Brand Name
AMD-RITMED
Version/Model Number
A94100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 27, 2019
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
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
aa21cfe1-c8b2-4d5b-a263-3db378419546
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
September 15, 2016
Package DI Number
20686864030243
Quantity per Package
16
Contains DI Package
10686864040108
Package Discontinue Date
August 27, 2019
Package Status
Not 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 |