Duns Number:017246562
Device Description: MALE L/L NON VENTED CAPS STERILE
Catalog Number
EC1000STA
Brand Name
Centurion
Version/Model Number
EC1000STA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
d401aa5a-cd3c-4c30-9d47-5df103cb9d63
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
00653160355260
Quantity per Package
400
Contains DI Package
10653160355267
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6043 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
| U | Unclassified | 1 |