Duns Number:969820245
Device Description: The PMT Cervical Visualization Harness stretches to conform to the outer shoulder while ho The PMT Cervical Visualization Harness stretches to conform to the outer shoulder while holding traction securely.It is used to achieve safe, effective traction on the shoulders for intraoperative cervical X-rays.
Catalog Number
PD-33-600
Brand Name
PMT Cervical Harness
Version/Model Number
PD-33-600
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
HST
Product Code Name
Apparatus, Traction, Non-Powered
Public Device Record Key
3ab860da-2b0a-40b8-8f26-f9a79816619d
Public Version Date
August 10, 2021
Public Version Number
1
DI Record Publish Date
August 02, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |