Duns Number:086911794
Device Description: A non-powdered patient disposable latex device intended for medical purposes that is worn A non-powdered patient disposable latex device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner. (144 count)
Catalog Number
70435
Brand Name
Medi-First Latex Medium Finger Cots
Version/Model Number
70435
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
-
Product Code
LZB
Product Code Name
Finger Cot
Public Device Record Key
f0467d61-b007-4aad-a442-231d812da1de
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
50347682704358
Quantity per Package
10
Contains DI Package
00347682704353
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |