Duns Number:061081477
Device Description: BITE REG S/P FS 50ML CART*2 #BR9002
Catalog Number
SP693118
Brand Name
SmartPractice
Version/Model Number
SP693118
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K992001,K992001,K992001
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
274a0be4-d763-4923-b764-bd5f33ad67b4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
D766SP6931182
Quantity per Package
10
Contains DI Package
D766SP6931181
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| U | Unclassified | 18 |