Maquet Rolite
ROL PWDII50SF B AIM CL K4
1manufacturer
35catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FSS |
| Device type | Light, Surgical, Floor Standing |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-04 |
| Record revised | 2023-09-20 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Handling environment temperature -10 to 60 °C; Handling environment humidity 20 to 75 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 75 % RH |
| Distribution end date | 2024-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARDROL309047A | In distribution | |
| ARDROL309046A | In distribution | |
| ARDROL309039A | In distribution | |
| ARDROL309053A | In distribution | |
| ARDROL309040A | In distribution | |
| ARDROL309056A | In distribution | |
| ARDROL309057A | In distribution | |
| ARDROL309044A | In distribution | |
| ARDROL309058A | In distribution | |
| ARDROL309045A | In distribution | |
| ARDROL309050A | In distribution | |
| ARDROL309054A | In distribution | |
| ARDROL309052A | In distribution | |
| ARDROL309043A | In distribution | |
| ARDROL309042A | In distribution | |
| ARDROL309051A | In distribution | |
| ARDROL309048A | In distribution | |
| ARDROL309041A | In distribution | |
| ARDROL309055A | In distribution | |
| ARDROL309049A | In distribution | |
| ARDROL309038A | Withdrawn | |
| ARDROL309031A | Withdrawn | |
| ARDROL309035A | Withdrawn | |
| ARDPWT309015A | Withdrawn | |
| ARDPWT309010A | Withdrawn | |
| ARDROL309037A | Withdrawn | |
| ARDPWT309002A | Withdrawn | |
| ARDPWT309001A | Withdrawn | |
| ARDPWT309009A | Withdrawn | |
| ARDPWT309006A | Withdrawn | |
| ARDPWT309008A | Withdrawn | |
| ARDPWT309016A | Withdrawn | |
| ARDROL309032A | Withdrawn | |
| ARDROL309033A | Withdrawn | |
| ARDPWT309007A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StarTrol | Huot Instruments, LLC | 9 |
| HarmonyAIR | Steris Corporation | 6 |
| Aesculap | Aesculap AG | 5 |
| Lucea LED® | Maquet Gmbh | 4 |
| Amtai | Amtai Medical Equipment, Inc. | 4 |
| Nico Myriad-LX | Nico Corporation | 3 |
| Sunoptic Technologies | Sunoptic Technologies, LLC | 3 |
| Aurora Surgical Light Series | Skytron, LLC | 2 |
| Maxx Luxx LED 160 | Avante | 2 |
| MS Sim.LED OpL wDB | S.i.m.e.o.n. Medical GMBH & Co.KG | 2 |
| STARLED3 NX | Acem SPA | 2 |
| Nico Myriad-LX | Sunoptic Technologies, LLC | 2 |
Showing 12 of 37. All products under Light, Surgical, Floor Standing
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.