MR8

Tool MR8-23TD3010 MR8 23CM TWSTDRL3X10MM

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code HBC
Manufacturer City Province Registered as Device types
Shenzhen Rainbow Technology Co., Ltd. Shenzhen Guangdong Manufacturer 12

Record

Regulatory record for MR8
Listed by Medtronic Ablation Frontiers, LLC, United States
FDA product code HBC
Device type Motor, Drill, Electric
Device class Class 2
Regulation 21 CFR 882.4360
510(k) K183515
Record published 2023-12-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for MR8
Catalogue number Size Status
MR8-23TD3010 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
NSK Sterile Burs/Drills Nakanishi Inc. 447
Motor, Drill, Electric Anspach Effort, The 168
Primado2 Nakanishi Inc. 96
Elan 4 Aesculap AG 39
Midas REX® Medtronic Powered Surgical Solutions 29
NSK Sterile Blades Nakanishi Inc. 24
Motor, Drill, Electric Synthes Gmbh 22
Aesculap Aesculap AG 14
SSG10 Saeshin Precision Co., Ltd. 11
Traus Saeshin Precision Co., Ltd. 9
Midas Rex MR8 Medtronic Powered Surgical Solutions 7
Eccos Aesculap AG 7

Showing 12 of 75. All products under Motor, Drill, Electric

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