Duns Number:073814568
Device Description: Toboggan Style (Curved) Surgical Arm Guards. Constructed of clear plexiglass making them Toboggan Style (Curved) Surgical Arm Guards. Constructed of clear plexiglass making them extremely durable and easy to clean. Can also be used to protect legs, sold as pair
Catalog Number
BDAS17
Brand Name
NA
Version/Model Number
BDAS17
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
3367590a-a12e-4be5-a02c-577ccff8ca1f
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 264 |