Duns Number:023001257
Device Description: The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed ove The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
Catalog Number
-
Brand Name
Soft K-Cot(R)
Version/Model Number
SFT-4200
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZS
Product Code Name
Curette, Surgical, General Use
Public Device Record Key
f78cf2ee-a2b3-48a6-a0a8-d56e9d623253
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 25, 2021
Package DI Number
10860275000368
Quantity per Package
250
Contains DI Package
00860275000361
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 | 5 |