Duns Number:055870299
Device Description: Jacobson Titanium Micro Needle Holder 21.5cm Flat Hdl w/lock, Str Jaw 0.8mm tip dia TCC
Catalog Number
-
Brand Name
ASSI
Version/Model Number
ASSI.CSLT21TCC
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
GZX
Product Code Name
Instrument, Microsurgical
Public Device Record Key
af4f0293-57cf-4d12-8e43-752071d1ed4f
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
June 30, 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 | 1975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 400 |