Duns Number:005085972
Device Description: Jackson Tissue Retractor
Catalog Number
TRJK
Brand Name
HU-FRIEDY
Version/Model Number
TRJK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 19, 2022
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIG
Product Code Name
RETRACTOR, ALL TYPES
Public Device Record Key
43dbbc4d-1b8e-4781-9aad-813f039f04a9
Public Version Date
January 20, 2022
Public Version Number
2
DI Record Publish Date
August 14, 2020
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 | 7436 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |