Duns Number:007941230
Device Description: Kit Driveline Management Includes Gloves Nitrile Wall Blue Chloraprep Swabstick 5.25ML 3 P Kit Driveline Management Includes Gloves Nitrile Wall Blue Chloraprep Swabstick 5.25ML 3 Pack Alcohol Prep Pad Medium 12Ply Gauze 3X3 Skin Prep Protective Wipes Adhesive Tape Remover Pads Micropore Tape 1X18 Tegaderm Adv 4X6.125 Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
CLC2000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K921394,K921394
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
79f58f1b-1fa6-4244-91c8-e8def13f710f
Public Version Date
October 06, 2020
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632137301
Quantity per Package
30
Contains DI Package
10885632137303
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 |