Duns Number:017246562
Device Description: STERILE PIPE CLEANERS 3 PER PK
Catalog Number
PC12SPST3
Brand Name
Centurion
Version/Model Number
PC12SPST3
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
MDM
Product Code Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Public Device Record Key
5fcc7c90-e031-4d6f-a5f0-77b2a0b13e5f
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 02, 2022
Package DI Number
00653160281316
Quantity per Package
100
Contains DI Package
10653160281313
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 |