A Supreme
Silk A Supreme Cover Right Size 13
3manufacturers in China registered for this device type
84catalogue 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 |
|---|---|---|
| C405R06 | In distribution | |
| 503 13R | In distribution | |
| C405L13 | In distribution | |
| C405R08 | In distribution | |
| 503 6R | In distribution | |
| C405R13 | In distribution | |
| 503 12R | In distribution | |
| C333L05 | In distribution | |
| C333L01 | In distribution | |
| 503 7L | In distribution | |
| C333R03 | In distribution | |
| 503 2R | In distribution | |
| C333R04 | In distribution | |
| C405R03 | In distribution | |
| C405L10 | In distribution | |
| C333L13 | In distribution | |
| 503 11R | In distribution | |
| C405R02 | In distribution | |
| 503 14R | In distribution | |
| C333R08 | In distribution | |
| 503 11L | In distribution | |
| C405R07 | In distribution | |
| C333R02 | In distribution | |
| C333R01 | In distribution | |
| C333L09 | In distribution | |
| 503 8L | In distribution | |
| C405R09 | In distribution | |
| 503 9R | In distribution | |
| 503 7R | In distribution | |
| C333L03 | In distribution | |
| 503 8R | In distribution | |
| C405R04 | In distribution | |
| C405L09 | In distribution | |
| C405L06 | In distribution | |
| 503 6L | In distribution | |
| C405L11 | In distribution | |
| C405L12 | In distribution | |
| C405L03 | In distribution | |
| 503 13L | In distribution | |
| C333L07 | In distribution | |
| C333R07 | In distribution | |
| 503 5L | In distribution | |
| 503 9L | In distribution | |
| C333R13 | In distribution | |
| C333R11 | In distribution | |
| C405L05 | In distribution | |
| 503 4R | In distribution | |
| C405R12 | In distribution | |
| 503 1R | In distribution | |
| 503 4L | In distribution | |
| C405L01 | In distribution | |
| C333L02 | In distribution | |
| 503 10R | In distribution | |
| 503 3L | In distribution | |
| C333R05 | In distribution | |
| C333R06 | In distribution | |
| 503 2L | In distribution | |
| C333L10 | In distribution | |
| C405R14 | In distribution | |
| C333R14 | In distribution | |
| C333R09 | In distribution | |
| C405L02 | In distribution | |
| C333L11 | In distribution | |
| C405L07 | In distribution | |
| C405R01 | In distribution | |
| 503 10L | In distribution | |
| 503 12L | In distribution | |
| C333L08 | In distribution | |
| C405R10 | In distribution | |
| 503 5R | In distribution | |
| 503 1L | In distribution | |
| C333R10 | In distribution | |
| C405R05 | In distribution | |
| C333L14 | In distribution | |
| C333R12 | In distribution | |
| C333L12 | In distribution | |
| C405L04 | In distribution | |
| 503 14L | In distribution | |
| C405L08 | In distribution | |
| C405L14 | In distribution | |
| 503 3R | In distribution | |
| C333L06 | In distribution | |
| C405R11 | In distribution | |
| C333L04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 179 |
| 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 |
| Symphony | Trulife, Inc. | 18 |
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.