Duns Number:791014871
Device Description: DK OR Towel,CSR Wrap,Softpack,ST 16"x26",Blue
Catalog Number
CT-08B
Brand Name
Dukal
Version/Model Number
CT-08B
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
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
29f946f1-e436-4302-be42-b6b4563590eb
Public Version Date
May 23, 2022
Public Version Number
8
DI Record Publish Date
September 15, 2017
Package DI Number
20665973000491
Quantity per Package
10
Contains DI Package
00665973000497
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |