Duns Number:187502109
Catalog Number
3105-000-801
Brand Name
PostFree
Version/Model Number
3105000801
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HST
Product Code Name
Apparatus, traction, non-powered
Public Device Record Key
244d6e2d-01b0-4025-b11e-65d19fd34ff1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2017
Package DI Number
37613327376341
Quantity per Package
1
Contains DI Package
07613327376340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |