Duns Number:132124061
Device Description: Nipple prosthesis, external906 ABC NippleMade of soft silicone with an adhesive back, this Nipple prosthesis, external906 ABC NippleMade of soft silicone with an adhesive back, this nipple prosthesis can be securely attached to a breast form, shaper, or reconstructed breast.Size SmallColor Tawny
Catalog Number
-
Brand Name
ABC Nipple
Version/Model Number
906-S-TW
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCZ
Product Code Name
Prosthesis, Breast, External, Used With Adhesive
Public Device Record Key
0a6daed9-1a3c-4337-9ea2-0561f200ba16
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |