Impressions Shell
Impressions Shell Extra Large
3manufacturers in China registered for this device type
5catalogue 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 |
|---|---|---|
| 110 S | In distribution | |
| 110 L | In distribution | |
| 110 XL | In distribution | |
| 110M | In distribution | |
| 110 KIT | 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.