Duns Number:086911794
Device Description: A non-powdered latex patient examination disposable device intended for medical purposes t A non-powdered latex patient examination disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner (144 count).
Catalog Number
70035
Brand Name
Medi-First Blue Large Latex Finger Cot
Version/Model Number
70035
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
525c0724-8c09-4f1f-aecf-8a48f5a2ad54
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
50347682700350
Quantity per Package
10
Contains DI Package
00347682700355
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 |