Duns Number:131084188
Device Description: REMOTE MEDICAL SPLINT 36IN FLAT ORANGE/BLUE
Catalog Number
-
Brand Name
SAM Splint
Version/Model Number
SP527-OB-EN-803
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NOC
Product Code Name
Splint, Extremity, Non-Inflatable, External, Non-Sterile
Public Device Record Key
2561f22c-8b19-4521-91a4-36e4223612f1
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10822045000534
Quantity per Package
60
Contains DI Package
00822045000537
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| U | Unclassified | 3 |