Silk Ultima Triangle
Silk Ultima Triangle Cover Size 14
3manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Dongguan Lanke Silicone Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| BUY Asia Enterprise Ltd | Dongguan | Guangdong | Private-label distributor | 22 |
Record
| Listed by | Trulife, Inc., United States |
|---|---|
| FDA product code | NOJ |
| Device type | Prosthesis, Breast, External, No Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C481 05 | In distribution | |
| C481 04 | In distribution | |
| C481 02 | In distribution | |
| C481 14 | In distribution | |
| C481 12 | In distribution | |
| C481 07 | In distribution | |
| C481 10 | In distribution | |
| C481 13 | In distribution | |
| C481 01 | In distribution | |
| C481 08 | In distribution | |
| C481 06 | In distribution | |
| C481 03 | In distribution | |
| C481 09 | In distribution | |
| C481 11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 179 |
| A Supreme | Trulife, Inc. | 84 |
| E Supreme | Trulife, Inc. | 34 |
| Bodicool Triangle | Trulife, Inc. | 31 |
| Silk Xtend | Trulife, Inc. | 28 |
| Bodicool Wave Triangle | Trulife, Inc. | 28 |
| Silk A Supreme | Trulife, Inc. | 28 |
| Bella | Trulife, Inc. | 26 |
| Silk Lite Partial | Trulife, Inc. | 26 |
| Impressions II | Trulife, Inc. | 23 |
| Sublime Arís | Trulife, Inc. | 21 |
| Luna | Trulife, Inc. | 20 |
Showing 12 of 37. All products under Prosthesis, Breast, External, No Adhesive
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.