Duns Number:109903521
Device Description: SWITCH DRAPE TENET 7633
Catalog Number
72203300
Brand Name
N/A
Version/Model Number
72203300
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDC
Product Code Name
TABLE, OPERATING-ROOM, ELECTRICAL
Public Device Record Key
b1efa792-2fec-4cfd-b031-4f83d29566f9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 20, 2016
Package DI Number
20885554023491
Quantity per Package
20
Contains DI Package
00885554023497
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 |