Duns Number:044611812
Device Description: SITE-RITE 8 ULTRASOUND SYSTEM W/ PHASER, US Refurbished
Catalog Number
9770501R
Brand Name
Site-Rite
Version/Model Number
9770501R
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
-
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
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
3763e1fc-b37a-46b8-a044-db6afc1646cf
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
10801741104135
Quantity per Package
1
Contains DI Package
00801741104138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |