Duns Number:131084188
Device Description: SUGAR TONG FOREARM SPLINT 23IN PEDIATRIC
Catalog Number
-
Brand Name
SAM Sugar Tong Splint
Version/Model Number
ST561-EN
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)
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
33bf7c9e-5633-446d-9fb6-1ef332a92f75
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
10822045428895
Quantity per Package
4
Contains DI Package
00822045428898
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 |