Duns Number:511139446
Device Description: Limb Holder with metal ring
Catalog Number
-
Brand Name
Salvacel
Version/Model Number
SVC2476
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
FMQ
Product Code Name
Restraint, protective
Public Device Record Key
634cde05-018a-4620-ba75-cc8d4a45ffd7
Public Version Date
December 02, 2019
Public Version Number
1
DI Record Publish Date
November 22, 2019
Package DI Number
08436035350414
Quantity per Package
24
Contains DI Package
08436035350407
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 170 |