Duns Number:057728685
Device Description: Sensor Sleeves, Size 1 Large (Clear) 1.625” x 8.5”
Catalog Number
-
Brand Name
Sensor Sleeves
Version/Model Number
BCXSL
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)
-
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
5a55aeb7-c90c-4dc9-80ba-6b140a68c51f
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
50732224003301
Quantity per Package
12
Contains DI Package
10732224003303
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |