Gen2

Septum Elevator, 7 3/8", DBL Ended, Strongly CVD, 2.0MM & 2.5MM Ball TIP Ends, Square Handle

Registry build 21.09.26
7manufacturers in China registered for this device type
80catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEG
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24

Record

Regulatory record for Gen2
Listed by Surgix Medical LLC, United States
FDA product code GEG
Device type Elevator, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-10-18
Record revised 2025-06-17 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Length 0.25 to 13.75 in; width 2.2 mm; length 18.5 cm
Distribution end date 2025-06-16

Catalogue Numbers

Catalogue numbers for Gen2
Catalogue number Size Status
G2N11501 Tip Width 0.75 inches In distribution
G2N11222 Length 10 in In distribution
G2E17507 Blade Length 12 mm In distribution
G2N11590 Length 8 in In distribution
G2N11562 Length 13 in In distribution
G2N49304 Length 7.5 in In distribution
G2N11127 Length 7.75 in In distribution
G2R12018 Length 13.25 in In distribution
G2N11514 Length 0.3125 in In distribution
G2N11561 Length 13 in In distribution
573-515 Length 7.125 in In distribution
G2N99556 Length 13.75 in In distribution
G2N11506 Length.25 in In distribution
G2N99463 Length 7.75 in In distribution
G2N11127 Length 7.75 in In distribution
G2N11523 tip width 0.5 inches In distribution
G2E11120 Tip Width 3 mm In distribution
G2N99505 Length 7.5 in In distribution
G2E30010 Length 6.25 in In distribution
G2N11512 Length 6.375 in In distribution
G2N11513 Length.25 in In distribution
G2N11511 In distribution
G2N11543 Length 7.25 in In distribution
G2N11506 Length.25 in In distribution
G2E2305 Length 9 in In distribution
G2N11553 Length 11 in In distribution
G2E901146 Length 6.25 in In distribution
G2N11562 Length 13 in In distribution
G2N11515 Length 6.5 in In distribution
G2E2320 Length 18.5 cm In distribution
G2E901344 Length 7.5 in In distribution
G2N35966 Length 7.75 in In distribution
G2N11531 In distribution
G2N11550 Length 11 in In distribution
G2E11120 Tip Width 3 mm In distribution
G2N11551 Length 11 in In distribution
G2N11545 Length 9.5 in In distribution
G2N11502 In distribution
G2N11501 Tip Width 0.75 inches In distribution
G2G35869 Length 7.75 in In distribution
G2N11321 Length 7.75 in In distribution
G2N11211 Length 6.5 in In distribution
G2E2314 Length 8.5 in In distribution
G2N11521 Tip Width.25MM In distribution
G2N11544 Tip size.375″ In distribution
G2E901343 Length 8.25 in In distribution
G2N11514 Length 0.3125 in In distribution
G2E17507 Blade Length 12 mm In distribution
G2N11320 Length 8.5 in In distribution
G2N49305 Length 7.5 in In distribution
G2N11554 Tip size 1.25″ In distribution
G2O917089 Length 7.25 in In distribution
G2O917087 Length 7.25 in In distribution
G2N11561 Length 13 in In distribution
G2N11545 Length 9.5 in In distribution
G2G35716 Length 12 in In distribution
G2N11531T Length 8 in In distribution
G2N11551 Length 11 in In distribution
G2N11515 Length 6.5 in In distribution
G2N11523 tip width 0.5 inches In distribution
G2N11368T Length 9 in In distribution
G2N11535 Length 6.5 in In distribution
G2E901291 Length 7.5 in In distribution
G2E1124 Tip Length 7 mm In distribution
G2N35966 Length 7.75 in In distribution
G2N11530 In distribution
G2N11223 Length 7 in In distribution
G2N35966 Length 7.75 in In distribution
G2N99580 Length 7.326 in In distribution
G2N11321 Length 7.75 in In distribution
G2N99493 Length 7 in In distribution
G2G36088 Length 6 in In distribution
G2N11552 Length 11 in In distribution
G2E1124 Tip Length 7 mm In distribution
G2N11543 Length 7.25 in In distribution
G2N11217 In distribution
G2N11552 Length 11 in In distribution
G2N11222 Length 10 in In distribution
G2N11590 Length 8 in In distribution
G2N11544 Length 9.5 in Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 531
Zoll-Dental Zoll-Dental 415
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 262
Millennium Avalign Technologies, Inc. 254
Surtex Surtex Instruments Ltd 243
Sklar Sklar Corporation 230
gSource Gsource, LLC. 190
Boss Instruments Boss Instruments, Ltd. 156
Aesculap Aesculap AG 131
Elevator KLS-Martin L.P. 119
Novo Surgical Inc. Novo Surgical, Inc. 104
Hayden Medical Hayden Medical Inc 103

Showing 12 of 173. All products under Elevator, Surgical, General & Plastic Surgery

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