StabiliT®

42 catalogue numbers from 00884450315903, listed by Merit Medical Systems, Inc., United States, under Cement, Bone, Vertebroplasty. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26
5manufacturers in China registered for this device type
42catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code NDN
Manufacturer City Province Registered as Device types
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Ningbo Hicren Biotechnology Co., Ltd. Ningbo Zhejiang Manufacturer 5
Jieno Youcheng Medical Technology (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 3
Dragon Crown Medical Co., Ltd. Jinan Shandong Manufacturer 2

Record

Regulatory record for StabiliT®
Listed by Merit Medical Systems, Inc., United States
FDA product code NDN
Device type Cement, Bone, Vertebroplasty
Device class Class 2
Regulation 21 CFR 888.3027
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2017-06-02
Record revised 2024-10-14 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Packaging Pack of 90

Catalogue Numbers

Catalogue numbers for StabiliT®
Catalogue number Size Status
00884450315903 Gauge-10/11G In distribution
00884450315897 Gauge-10/11G In distribution
00884450413999 Size-Short In distribution
F In distribution
B In distribution
00884450317648 Gauge-10/11G In distribution
00884450325704 Gauge-10/11G In distribution
00884450325766 Size-Short In distribution
00884450325667 In distribution
G In distribution
D In distribution
00884450317631 Size-Long In distribution
G In distribution
00884450315910 Size-Short In distribution
00884450325612 Gauge-10/11G In distribution
00884450379905 Gauge-10/11G In distribution
00884450325605 Gauge-10/11G In distribution
F In distribution
D In distribution
B In distribution
00884450296462 Gauge-10/11G In distribution
00884450441459 Gauge-10/11G In distribution
F In distribution
00884450314081 In distribution
00884450314074 In distribution
00884450379844 Gauge-10/11G In distribution
00884450314487 Gauge-10/11G In distribution
00884450379820 Size-Short In distribution
00884450296509 Size-Short In distribution
00884450314319 Size-Long In distribution
F In distribution
B In distribution
00884450317655 Size-Long In distribution
00884450296301 Size-Long In distribution
00884450503331 In distribution
00884450379851 Gauge-10/11G In distribution
00884450379837 Size-Short In distribution
00884450296271 Size-Long In distribution
F In distribution
00884450315927 Size-Short In distribution
00884450325643 Size-Long In distribution
00884450317662 Size-Short In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Zavation Zavation 284
CD Horizon® Fenestrated Screw Set Medtronic Sofamor Danek, Inc. 88
Medinaut Plus Kyphoplasty System Imedicom Co., Ltd. 41
iVAS Stryker GmbH 35
V-Strut Vertebral Implant Hyprevention 28
Tracker Plus Kyphoplasty System GS Medical Co., Ltd. 25
StabiliT MX Fracture Kit Dfine, Inc. 12
Osseoflex® Merit Medical Systems, Inc. 8
Synth™ BES Imedicom Co., Ltd. 8
Tracker GS Medical Co., Ltd. 6
AVAflex Stryker GmbH 6
Spider Kolibri Sintea Plustek 6

Showing 12 of 210. All products under Cement, Bone, Vertebroplasty

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