Duns Number:078352849
Device Description: Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area
Catalog Number
Retractor T&C Small
Brand Name
Retractor - Tongue and Cheek
Version/Model Number
Retractor T&C Small
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIG
Product Code Name
Retractor, All Types
Public Device Record Key
1ba18635-5083-4d04-a7a8-9917cf744ffa
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |