Duns Number:053146767
Device Description: NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive su NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm.
Catalog Number
NL 100
Brand Name
NL 100 Breast Marker
Version/Model Number
NL 100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
7bed0428-56d5-434b-b1aa-310e42af44b9
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
Package DI Number
M996NL1004
Quantity per Package
25
Contains DI Package
M996NL1000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |