Duns Number:109903521
Device Description: SURGICAL ASSISTANT LOW PROFILE DISPOSABLE FOAM INSERT, SURGICAL ASSISTANT LOW PROFILE DISPOSABLE FOAM INSERT, BLUE 20 PER BOX
Catalog Number
7209459
Brand Name
SURGICAL ASSISTANT
Version/Model Number
7209459
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
FWZ
Product Code Name
Accessories, operating-room, table (kit)
Public Device Record Key
c1c86f0b-984c-484e-8688-ea209e218883
Public Version Date
October 09, 2020
Public Version Number
5
DI Record Publish Date
August 30, 2015
Package DI Number
23596010468738
Quantity per Package
20
Contains DI Package
03596010468734
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |