ArcCHECK Pmma MultiPlug

Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR.

Registry build 21.09.26
3manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code LHO
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Nanjing Jusha Display Technology Co., Ltd. Nanjing Jiangsu Manufacturer 7

Record

Regulatory record for ArcCHECK Pmma MultiPlug
Listed by Sun Nuclear Corporation, United States
FDA product code LHO
Device type Instrument, Quality-Assurance, Radiologic
Device class Class 1
Regulation 21 CFR 892.1940
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2017-01-14
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety MR Conditional
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment temperature 10 to 40 °C; Storage environment humidity 30 to 60 % RH; Handling environment temperature -20 to 60 °C; Handling environment humidity 10 to 70 °C; Special storage condition: Store the ArcCHECK, ancillary parts, and accessories in an indoor, climate-controlled environment consistent with specif

Catalogue Numbers

Catalogue numbers for ArcCHECK Pmma MultiPlug
Catalogue number Size Status
12200003Z In distribution
1220000-3Z In distribution

Same Product Code

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Showing 12 of 163. All products under Instrument, Quality-Assurance, Radiologic

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer