Gigli Saw Handle

A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an…

Registry build 21.09.26

A hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. This is a reusable device.

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

Who Else Makes It

Concentrated in Shandong (1), Jiangsu (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDR
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shenzhen Airgle Corporation Limited Shenzhen Guangdong Manufacturer 4

Record

Regulatory record for Gigli Saw Handle
Listed by N S Surgical Company
FDA product code GDR
Device type Saw, Manual And Accessories
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2023-04-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Moist Heat or Steam Sterilization, Ultraviolet Light
Label carries lot or batch number, manufacturing date
Sizes Length 9 cm

Catalogue Numbers

Catalogue numbers for Gigli Saw Handle
Catalogue number Size Status
07-066-06 Length 9 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 23
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 20
Aesculap Aesculap AG 19
gSource Gsource, LLC. 16
Integra® Miltex® Integra LifeSciences Production Corporation 14
ACE Ace Surgical Supply Co., Inc. 14
Boss Instruments Boss Instruments, Ltd. 11
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 11
Integra® Jarit® Integra LifeSciences Production Corporation 10
Novo Surgical Inc. Novo Surgical, Inc. 10
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 10
Kmedic Teleflex Medical LLC 8

Showing 12 of 46. All products under Saw, Manual And Accessories

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