Duns Number:012430880
Device Description: Chair Cover
Catalog Number
5701933
Brand Name
Henry Schein
Version/Model Number
5701933
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NRU
Product Code Name
CHAIR, DENTAL, WITHOUT OPERATIVE UNIT
Public Device Record Key
e20f6a7b-9d59-4b52-b761-03018d9da1ea
Public Version Date
March 20, 2020
Public Version Number
1
DI Record Publish Date
March 12, 2020
Package DI Number
20304040131361
Quantity per Package
4
Contains DI Package
10304040131364
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |