Duns Number:825137818
Device Description: CHAIR SLEEVE HALF 27.5 x 24
Catalog Number
9508292
Brand Name
Darby Dental Supply, LLC
Version/Model Number
D112
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
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
-
Product Code
PEM
Product Code Name
Dental barriers and sleeves
Public Device Record Key
531c88d5-7ffc-4ca9-b0e2-caa1dcbbb8a9
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
June 24, 2016
Package DI Number
20889813001411
Quantity per Package
3
Contains DI Package
10889813001414
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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |