Duns Number:040876183
Device Description: ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm long. Cas ArmGuard BASIC Packs - Each Pack contains 2 padded arm protectors, 20 in 51 cm long. Case of 12 ea. 00811836030396 (model #40103)
Catalog Number
-
Brand Name
ArmGuard™
Version/Model Number
40101
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)
-
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
175a87db-ae88-4e14-8980-029cbacc3978
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
May 17, 2021
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 | 28 |