STar™ Drive Insertion Tube Set

STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19)…

Registry build 21.09.26

STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet – 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet – 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors

4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Beijing (1).

Chinese manufacturers registered for FDA product code HAO
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33
Hotry Co., Ltd. Beijing Beijing Manufacturer 9

Record

Regulatory record for STar™ Drive Insertion Tube Set
Listed by FHC, Inc., United States
FDA product code HAO
Device type Instrument, Surgical, Non-Powered
Device class Class 1
Regulation 21 CFR 882.4535
Establishment Complaint-file establishment, Manufacturer
Record published 2016-09-17
Record revised 2022-12-09 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature 0 to 40 °C; Storage environment humidity up to 95 % RH
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for STar™ Drive Insertion Tube Set
Catalogue number Size Status
70-IT-04-00218 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 705
Ambler Surgical Ambler Surgical, LLC 597
V. Mueller Steris Corporation 577
Millennium Avalign Technologies, Inc. 383
Avalign Avalign Technologies, Inc. 352
Novo Surgical Novo Surgical, Inc. 300
Novo Surgical Inc. Novo Surgical, Inc. 283
Boss Instruments Boss Instruments, Ltd. 263
Pilling Teleflex Medical LLC 156
Instrument, Surgical, Non-Powered Karl Storz GmbH & Co. KG 130
Instrument, Surgical, Non-Powered Fehling Instruments GmbH 126
Integra® Jarit® Integra LifeSciences Production Corporation 109

Showing 12 of 249. All products under Instrument, Surgical, Non-Powered

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