Duns Number:086911794
Device Description: A small, narrow, flexible band of fabric material coated on one side with a pressure-sensi A small, narrow, flexible band of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad, typically intended to cover a superficial wound.
Catalog Number
61715
Brand Name
Medi-First Extra Large Flexible Fingertip HW
Version/Model Number
61715
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
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
be312f20-a071-416c-94aa-c31b0276a0d1
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 02, 2019
Package DI Number
50347682617153
Quantity per Package
1000
Contains DI Package
00347682617158
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master cvase
| 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 |