Duns Number:078436895
Device Description: Soft, ultra-thin, flexible orthotic for bunions (hallux valgus) and bunionettes (tailor's Soft, ultra-thin, flexible orthotic for bunions (hallux valgus) and bunionettes (tailor's bunion). The full coverage toe hood covers the big toe and is secured with a heel strap.
Catalog Number
-
Brand Name
BunionETTE Bootie
Version/Model Number
LargeRight
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
ILG
Product Code Name
Stocking, Elastic
Public Device Record Key
fba7408b-dcb9-47fe-878e-bd267ae1ca3e
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |