Duns Number:315427286
Device Description: LinguSil transfer matrix for indirect bonding, Polyvinylsiloxane) / For further informatio
Catalog Number
-
Brand Name
N.A.
Version/Model Number
164-000-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2022
Issuing Agency
In HIBCC
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
Yes
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
K913537
Product Code
EWL
Product Code Name
PROSTHESIS, LARYNGEAL (TAUB)
Public Device Record Key
61576f18-aea1-4983-b53d-6a10152bee2d
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
September 15, 2016
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |