Dannik
DANNIK Titanium Ligation Clips are made of titanium and supplied in small, medium, medium-large and large sizes. They are packaged in cartridges of six and described as single-use devices.…
DANNIK Titanium Ligation Clips are made of titanium and supplied in small, medium, medium-large and large sizes. They are packaged in cartridges of six and described as single-use devices.
The stated intended use is ligating blood vessels. The filing also describes applications in surgical procedures where hemostasis or radiographic marking is needed.
Listed Item
Titanium Ligation Clip, Medium/Large
Clip Function
The filing says the clip is designed to occlude vessels and prevent slippage once applied. It directs the user to choose a size that fits the procedure and tissue to be occluded.
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Dannik, United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K192711 |
| Record published | 2023-01-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TCM200 | 20 | In distribution | |
| TCS100 | 20 | In distribution | |
| TCML300 | 20 | In distribution | |
| TCL400 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 321 |
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Aesculap | Aesculap AG | 19 |
| Medline | Medline Industries, Inc. | 15 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| E-Pack | Ethicon, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192711 | 2019-12-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.