Who else makes this device?

Name: Disposable Drill Stop Wrench
Brand: Disposable Drill Stop Wrench

Neurology › SurgicalDrills, Burrs, Trephines & Accessories (Manual)

Disposable Drill Stop Wrench

Catalogue number DDSW-N, listed by AD-Tech Medical Instrument Corp., United States, under Drills, Burrs, Trephines & Accessories (Manual). 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HBG
Manufacturer	City	Province	Registered as	Device types
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Shanghai Wilpower Industrial Co., Ltd.	Shanghai	Shanghai	Exporter	33

Record

Regulatory record for Disposable Drill Stop Wrench
Listed by	AD-Tech Medical Instrument Corp., United States
FDA product code	HBG
Device type	Drills, Burrs, Trephines & Accessories (Manual)
Device class	Class 2
Regulation	21 CFR 882.4300
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2017-12-27
Record revised	2023-08-23 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Sterilisation	Ethylene Oxide
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Catalogue Numbers

Catalogue numbers for Disposable Drill Stop Wrench
Catalogue number	Size	Status
DDSW-N		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	508
Integra® Jarit®	Integra LifeSciences Production Corporation	172
Integra® Miltex®	Integra LifeSciences Production Corporation	65
Drills, Burrs, Trephines & Accessories (Manual)	Synthes Gmbh	34
Integra®	Integra Pain Management	7
Symmetry Surgical	Aspen Surgical Products, Inc.	6
Symmetry Hudson	Aspen Surgical Products, Inc.	5
Symmetry Cushing	Aspen Surgical Products, Inc.	4
V. Mueller	Steris Corporation	3
SmartTip	ClearPoint Neuro Inc.	3
Drill Bit	Neurovention, LLC	2
Codman®	Integra LifeSciences Production Corporation	2

Showing 12 of 41. All products under Drills, Burrs, Trephines & Accessories (Manual)

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-08-27	Class II	Under Investigation by firm	The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.	315 units	2023-04-05

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.