Duns Number:026301221
Device Description: FARROW 15-20 MM HG TOE CAP LARGE TAN 1
Catalog Number
7102703
Brand Name
Farrow Toe Cap
Version/Model Number
7102703
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDR
Product Code Name
BINDER, MEDICAL, THERAPEUTIC
Public Device Record Key
087048ca-da61-4595-b2e3-cc0dbd16f131
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
April 11, 2018
Package DI Number
04042809612721
Quantity per Package
275
Contains DI Package
04042809612714
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3716 |