Duns Number:073436164
Device Description: Woven Tape Measure
Catalog Number
-
Brand Name
IMCO
Version/Model Number
396-IMC
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
47b15517-11a5-4886-a5be-0a8422cd59e4
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
June 16, 2016
Package DI Number
10815842023400
Quantity per Package
60
Contains DI Package
00815842023403
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |