Duns Number:447228586
Device Description: DISPOSABLE AUTOMATIC DEVICE 18G X 100 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm
Catalog Number
TY1810
Brand Name
Themy
Version/Model Number
TY1810
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
0a91d6f3-01a8-4ce7-8e6a-d3da11afe5ce
Public Version Date
June 01, 2021
Public Version Number
1
DI Record Publish Date
May 24, 2021
Package DI Number
28056138586721
Quantity per Package
5
Contains DI Package
08056138586727
Package Discontinue Date
-
Package Status
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 |