Duns Number:447228586
Device Description: THEMY AUTOMATIC NEEDLE 18Gx100mmNOTCH 20mm, WITH COAXIAL NEEDLEFOR SOFT TISSUE BIOPSY
Catalog Number
TYC1810
Brand Name
Themy
Version/Model Number
TYC1810
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
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
K160316,K160316
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
48e883b5-8ecb-4a83-8bd1-d1ce2f869cb4
Public Version Date
May 27, 2021
Public Version Number
7
DI Record Publish Date
January 04, 2017
Package DI Number
08052440109784
Quantity per Package
5
Contains DI Package
08052440100170
Package Discontinue Date
May 14, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 228 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |