Duns Number:023001257
Device Description: SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the pu SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.
Catalog Number
SBX-9000
Brand Name
SpiraBrush CX
Version/Model Number
SBX-9000
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011488,K011488
Product Code
HFB
Product Code Name
Forceps, Biopsy, Gynecological
Public Device Record Key
1c44b40c-03f0-4a88-910e-55438bdb76fd
Public Version Date
November 11, 2019
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
10860275000306
Quantity per Package
250
Contains DI Package
00860275000309
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 |