Duns Number:007941230
Device Description: Adhesive Skin Liquiband Flow Control N-Butyl 0.5 Gram Sterile Not Made With Natural Rubber Adhesive Skin Liquiband Flow Control N-Butyl 0.5 Gram Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
LFC002MC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122446,K122446,K122446
Product Code
MPN
Product Code Name
Tissue adhesive for the topical approximation of skin
Public Device Record Key
771509dc-bcbd-407f-a5c0-65b1581d919d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
30885632134337
Quantity per Package
12
Contains DI Package
10885632134333
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |