Duns Number:483016148
Device Description: SPREADER
Catalog Number
LIN-00 00 07-N
Brand Name
JULIET ® INSTRUMENTATION
Version/Model Number
LIN-00 00 07-N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
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
HWN
Product Code Name
Instrument, Compression
Public Device Record Key
fcfe8786-c519-4733-ac9d-c34e58f17b26
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
February 01, 2019
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 | 974 |
2 | A medical device with a moderate to high risk that requires special controls. | 5209 |