Trulife
Breast Prothesis Cover (Impressions II Encore / Silk Encore Triangle) Size 13
3manufacturers in China registered for this device type
179catalogue 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 |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N007R04 | In distribution | |
| 00630B03 | In distribution | |
| N00607 | In distribution | |
| 00630B08 | In distribution | |
| N00610 | In distribution | |
| 0063007 | In distribution | |
| D00101 | In distribution | |
| C399L00 | In distribution | |
| N007R12 | In distribution | |
| D00102 | In distribution | |
| D00105 | In distribution | |
| C399L12 | In distribution | |
| C399R08 | In distribution | |
| 0063012 | In distribution | |
| N00510 | In distribution | |
| 00630B09 | In distribution | |
| N007R10 | In distribution | |
| 0060704 | In distribution | |
| N007R07 | In distribution | |
| N00503 | In distribution | |
| 00630B05 | In distribution | |
| N00306 | In distribution | |
| N00601 | In distribution | |
| C399L04 | In distribution | |
| 00630N03 | In distribution | |
| C399R04 | In distribution | |
| 00630B11 | In distribution | |
| N007L08 | In distribution | |
| N007L12 | In distribution | |
| 0063008 | In distribution | |
| N007L13 | In distribution | |
| 630JD09 | In distribution | |
| N00311 | In distribution | |
| 0060708 | In distribution | |
| N00509 | In distribution | |
| N007L02 | In distribution | |
| N00608 | In distribution | |
| C399R06 | In distribution | |
| 00630B04 | In distribution | |
| 630JD06 | In distribution | |
| C399R12 | In distribution | |
| D00104 | In distribution | |
| 00630N09 | In distribution | |
| N00513 | In distribution | |
| D00113 | In distribution | |
| N00501 | In distribution | |
| N00614 | In distribution | |
| C399L11 | In distribution | |
| C399L09 | In distribution | |
| 00630B06 | In distribution | |
| C399L10 | In distribution | |
| 00630N13 | In distribution | |
| N00512 | In distribution | |
| N00516 | In distribution | |
| D00116 | In distribution | |
| N00313 | In distribution | |
| 0063002 | In distribution | |
| N00511 | In distribution | |
| 630JD10 | In distribution | |
| 00630N06 | In distribution | |
| 0063009 | In distribution | |
| C399R02 | In distribution | |
| N007R01 | In distribution | |
| 630JD13 | In distribution | |
| N007L11 | In distribution | |
| C399R07 | In distribution | |
| C399L01 | In distribution | |
| 630JD11 | In distribution | |
| 00630N14 | In distribution | |
| C399L05 | In distribution | |
| N007R11 | In distribution | |
| 00630B14 | In distribution | |
| N007R06 | In distribution | |
| 630JD03 | In distribution | |
| 00630N08 | In distribution | |
| 630JD08 | In distribution | |
| 00630B13 | In distribution | |
| N007R02 | In distribution | |
| N007L05 | In distribution | |
| 630JD05 | In distribution | |
| D00107 | In distribution | |
| C399R01 | In distribution | |
| D00112 | In distribution | |
| N00303 | In distribution | |
| D00110 | In distribution | |
| N007R13 | In distribution | |
| D00109 | In distribution | |
| N007R14 | In distribution | |
| N007L01 | In distribution | |
| 630JD07 | In distribution | |
| C399R00 | In distribution | |
| D00106 | In distribution | |
| D00114 | In distribution | |
| C399R05 | In distribution | |
| N00602 | In distribution | |
| C399L07 | In distribution | |
| N00506 | In distribution | |
| 0060709 | In distribution | |
| N00611 | In distribution | |
| 0063003 | In distribution | |
| 0060712 | In distribution | |
| C399L03 | In distribution | |
| 0063011 | In distribution | |
| N00305 | In distribution | |
| 0060710 | In distribution | |
| 0063013 | In distribution | |
| N00310 | In distribution | |
| 0060706 | In distribution | |
| C399R11 | In distribution | |
| C399R09 | In distribution | |
| C399L08 | In distribution | |
| 0063004 | In distribution | |
| N00508 | In distribution | |
| C399R14 | In distribution | |
| 00630N10 | In distribution | |
| C399L02 | In distribution | |
| N00517 | In distribution | |
| 0060703 | In distribution | |
| N007L14 | In distribution | |
| N007L07 | In distribution | |
| 0063006 | In distribution | |
| N00613 | In distribution | |
| D00115 | In distribution | |
| C399L06 | In distribution | |
| N00302 | In distribution | |
| N00515 | In distribution | |
| N00514 | In distribution | |
| C399L14 | In distribution | |
| N00309 | In distribution | |
| N007R09 | In distribution | |
| N007R03 | In distribution | |
| 630JD12 | In distribution | |
| N00505 | In distribution | |
| N00609 | In distribution | |
| N00604 | In distribution | |
| 00630N07 | In distribution | |
| 0060711 | In distribution | |
| 0060707 | In distribution | |
| 0063014 | In distribution | |
| 00630N04 | In distribution | |
| N00507 | In distribution | |
| 00630N05 | In distribution | |
| 0063001 | In distribution | |
| N00605 | In distribution | |
| N00312 | In distribution | |
| N00502 | In distribution | |
| 0063010 | In distribution | |
| N007L04 | In distribution | |
| C399R13 | In distribution | |
| N00504 | In distribution | |
| 630JD14 | In distribution | |
| N007R08 | In distribution | |
| 00630N12 | In distribution | |
| 00630B12 | In distribution | |
| N00308 | In distribution | |
| D00117 | In distribution | |
| D00103 | In distribution | |
| C399R10 | In distribution | |
| N00612 | In distribution | |
| D00111 | In distribution | |
| D00108 | In distribution | |
| C399R03 | In distribution | |
| N007L06 | In distribution | |
| 00630B10 | In distribution | |
| N00307 | In distribution | |
| N007R05 | In distribution | |
| N00603 | In distribution | |
| 630JD04 | In distribution | |
| N00314 | In distribution | |
| C399L13 | In distribution | |
| 00630B07 | In distribution | |
| N007L09 | In distribution | |
| 00630N11 | In distribution | |
| 0060705 | In distribution | |
| 0063005 | In distribution | |
| N00606 | In distribution | |
| N00304 | In distribution | |
| N007L03 | In distribution | |
| N007L10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.