Duns Number:080506581
Device Description: P.F.C. PATELLAR CALIPER
Catalog Number
869188
Brand Name
P.F.C.
Version/Model Number
86-9188
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTY
Product Code Name
TAPE, MEASURING, RULERS AND CALIPERS
Public Device Record Key
ad40dfa3-e189-4a9e-bd00-4046590a9621
Public Version Date
August 02, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2015
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 | 5254 |
2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
3 | A medical device with high risk that requires premarket approval | 908 |