ENT MR8

Attachment 1847ATTSS ENTMR8 Straight STD

Registry build 21.09.26
2manufacturers in China registered for this device type
234catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code ERL
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Guangdong Jinme Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 13

Record

Regulatory record for ENT MR8
Listed by Medtronic Powered Surgical Solutions, United States
FDA product code ERL
Device type Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class Class 2
Regulation 21 CFR 874.4250
Establishment Specification developer, Manufacturer
510(k) K183515
Record published 2020-10-02
Record revised 2022-09-16 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for ENT MR8
Catalogue number Size Per pack Status
1847B50SDF In distribution
1847TRAY In distribution
1847B10LDC In distribution
1847ATTSS In distribution
1847B15SCF In distribution
1847B30SDF In distribution
1847B40SCT In distribution
1847ATTAV-R In distribution
1847B20LCT In distribution
1847B50SDC In distribution
1847B10LDC In distribution
1847B30LDC In distribution
1847B50SDX In distribution
1847B70SCT In distribution
1847B15SCT In distribution
1847B30LCF In distribution
1847B30LCT In distribution
1847CV15SCT In distribution
1847B15SDC In distribution
1847B10LCT In distribution
1847B40SDX In distribution
1847B10SDM In distribution
1847B05LCT In distribution
1847B40SDM In distribution
1847B60SCC In distribution
1847B20LDM In distribution
1847B10LCF In distribution
1847B15LCF In distribution
1847B20SDF In distribution
1847B70SDC In distribution
1847B25LDF In distribution
1847CV40SCT In distribution
1847B20SCT In distribution
1847B30LCT In distribution
1847B30SDF In distribution
1847B20LCF In distribution
1847B60SDM In distribution
1847B25SDF In distribution
1847CV40LDF In distribution
1847B20LCT In distribution
1847B25SCT In distribution
1847B50SDM In distribution
1847B60SDX In distribution
1847B60SDF In distribution
1847WRENCH In distribution
1847B35SDM In distribution
1847B25SCF In distribution
1847B40SDC In distribution
1847B15SDF In distribution
1847CV20LDF In distribution
1847CV12SDF In distribution
1847B20LDF In distribution
1847B10SDC In distribution
1847B60SCC In distribution
1847B70SCC In distribution
1847B10LCF In distribution
1847B15LDC In distribution
1847B25SDM In distribution
1847B40LDC In distribution
1847B20LDF In distribution
1847CV05SDF In distribution
1847CV20LDC In distribution
1847B35LCT In distribution
1847CV30SCT In distribution
1847BRACK In distribution
1847B15SCF In distribution
1847CV20SDF In distribution
1847B10LDM In distribution
1847CV40LCT In distribution
1847B50SCT In distribution
1847B40SCT In distribution
1847B80SCT In distribution
1847B35SCT In distribution
1847B20LCF In distribution
1847B06LDM In distribution
1847B20SDM In distribution
1847ATTAS-R In distribution
1847B35LDM In distribution
1847B10LDF In distribution
1847B08LDM In distribution
1847B25LDM In distribution
1847B25LDM In distribution
1847B70SDM In distribution
1847B30LDM In distribution
1847B30SDM In distribution
1847B60SCT In distribution
1847B60SCF In distribution
1847B10SCT In distribution
1847B30LCF In distribution
1847B10SDM In distribution
1847CV20LCT In distribution
1847B25LCT In distribution
1847DRLMTR-R In distribution
1847B50LDF In distribution
1847B50SDC In distribution
1847DRLMTR In distribution
1847B15SDM In distribution
1847B25SDF In distribution
1847B15SDC In distribution
1847B20SDC In distribution
1847CV20SCT In distribution
1847CV20LDF In distribution
1847B25LCF In distribution
1847CV30SDC In distribution
1847B08LDM In distribution
1847B15SDM In distribution
1847B50SDX In distribution
1847CV40LDC In distribution
1847B20SCT In distribution
1847B50SCF In distribution
1847B25LDF In distribution
1847B35LCF In distribution
1847B15LCT In distribution
1847B30SCC In distribution
1847B35SDM In distribution
1847BRUSH 5 In distribution
1847B12LDM In distribution
1847ATTAV In distribution
1847B10SCF In distribution
1847B40SCC In distribution
1847B40LDC In distribution
1847B20SDF In distribution
1847B10SDF In distribution
1847CV40SDC In distribution
1847B30SCF In distribution
1847B20LDC In distribution
1847B50SCT In distribution
1847B60SDC In distribution
1847B15LDF In distribution
1847B30LDC In distribution
1847ATTAS In distribution
1847CV10LDF In distribution
1847B25SDM In distribution
1847B50SCF In distribution
1847CV30SDF In distribution
1847B15SCT In distribution
1847B15LCF In distribution
1847CV10LDF In distribution
1847B25SDC In distribution
1847B30SCT In distribution
1847B20LDC In distribution
1847CV30LDF In distribution
1847B70SCT In distribution
1847B80SCT In distribution
1847CV10LCT In distribution
1847B35LCF In distribution
1847B50SDM In distribution
1847B25SDC In distribution
1847CV30LDF In distribution
1847B40LDM In distribution
1847B20SCF In distribution
1847B30SDC In distribution
1847CV30LDC In distribution
1847B25LCF In distribution
1847B15LDF In distribution
1847B60SDC In distribution
1847B40SDF In distribution
1847B30SCC In distribution
1847B40LDF In distribution
1847B15LCT In distribution
1847CV30LCT In distribution
1847B60SDX In distribution
1847B40SCF In distribution
1847B12LDM In distribution
1847B60SDM In distribution
1847B30LDF In distribution
1847B15LDC In distribution
1847ATTSV-R In distribution
1847B30SCT In distribution
1847B20SDC In distribution
1847B25SCF In distribution
1847B25LCT In distribution
1847CV30SDF In distribution
1847B50SCC In distribution
1847B50SDF In distribution
1847B20SCF In distribution
1847CV15LCT In distribution
1847B10SDC In distribution
1847B80SDM In distribution
1847B35LCT In distribution
1847CV40SDF In distribution
1847CV08SDF In distribution
1847B40LDM In distribution
1847B40SDX In distribution
1847B10SCT In distribution
1847B50SCC In distribution
1847B10SCC In distribution
1847B20LDM In distribution
1847B30SDM In distribution
1847B10LDF In distribution
1847B50LDF In distribution
1847B40SDF In distribution
1847B25SCT In distribution
1847B35SCT In distribution
1847B10SCC In distribution
1847ATTSS-R In distribution
1847CV10SDF In distribution
1847B20SCC In distribution
1847B40SCC In distribution
1847B70SDC In distribution
1847B35LDC In distribution
1847B80SCC In distribution
1847B20SCC In distribution
1847B30SDC In distribution
1847B06LDM In distribution
1847B30LDM In distribution
1847B60SCT In distribution
1847B10SCF In distribution
1847ATTSV In distribution
1847B35LDC In distribution
1847B10LDM In distribution
1847B60SDF In distribution
1847B70SDM In distribution
1847B40SCF In distribution
1847B35LDM In distribution
1847B80SCC In distribution
1847B15SDF In distribution
1847B15LDM In distribution
1847B80SDM In distribution
1847CV10SCT In distribution
1847B40SDM In distribution
1847B30LDF In distribution
1847B05LCT In distribution
1847B10LCT In distribution
1847B60SCF In distribution
1847B15LDM In distribution
1847CV15SDF In distribution
1847B70SCC In distribution
1847B10SDF In distribution
1847B20SDM In distribution
1847CV20SDC In distribution
1847B40SDC In distribution
1847B40LDF In distribution
1847B30SCF In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Anspach Effort, The 214
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Karl Storz GmbH & Co. KG 208
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Synthes Gmbh 126
Midas Rex Medtronic Powered Surgical Solutions 97
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Stryker GmbH 87
Midas REX Microsaws Medtronic Powered Surgical Solutions 75
Piezomed Pro Accessory W&H Dentalwerk Bürmoos GmbH 50
Midas Rex Clearview™ Medtronic Xomed, Inc. 47
Zethon Zethon Ltd 39
NSK Sterile Burs/Drills Nakanishi Inc. 34
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Medtronic Xomed, Inc. 29
Core Stryker GmbH 27

Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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