GEN2

Balfour Retractor, 6 piece set BL 70mm, BW 84mm, Arm length 150mm OL 385mm(15 1/8")

Registry build 21.09.26
34manufacturers in China registered for this device type
258catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAD
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
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
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74

Showing 12 of 34. All 34 manufacturers in China registered for Retractor

Record

Regulatory record for GEN2
Listed by Surgix Medical LLC, United States
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-08-21
Record revised 2022-12-09 (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 0.75 to 14.5 in; width 0.5 to 3 in; length 4.7 to 385 mm; width 9 to 43 mm; angle 25 to 135 °; length 3 to 19 cm; depth 64 mm; depth 2 in
Distribution end date 2025-06-16

Catalogue Numbers

Catalogue numbers for GEN2
Catalogue number Size Status
G2N99500 Length 8.25 in In distribution
G2N99490 Length 6 in In distribution
G2N52542 Length 7.5 in In distribution
G2G23660 Length 8 in In distribution
G2N52586 Length 8 in In distribution
G2N52128 Length 3 cm In distribution
G2G37077 Length 9 in In distribution
G2N99470 Length 11 in In distribution
G2G23010 Length 6.25 in In distribution
G2G35916 tip width 2.5 inches In distribution
G2N52503 Length 6.87 in In distribution
G2G23580 Length 8 in In distribution
G2G23400 Length 10 in In distribution
G2N52286 Length 11 in In distribution
G2G2424 Length 7.5 in In distribution
G2N99370 Length 7.5 in In distribution
G2N99373 Length 9 in In distribution
G2G37278 Length 9 in In distribution
G2G23590 Length 8 in In distribution
G2G37017 Length 9.5 in In distribution
G2N52101 Tip Length.5mm In distribution
G2N52308 Length 11.75 in In distribution
G2N52582 Length 5.5 in In distribution
G2G23180 Length 9.25 in In distribution
G2N52543 Length 7.5 in In distribution
G2G23140 Length 9.375 in In distribution
G2N52305 Length 3 in In distribution
G2N52581 Length 5.5 in In distribution
G2N52231 Length 5.5 in In distribution
G2N52105 Direction Straight In distribution
G2N99612 Length 70 mm In distribution
G2E14190 Length 5.125 in In distribution
G2G37275 90mm x 25mm blade In distribution
G2G35706 Tip Length 80 mm In distribution
G2G36911 Length 8.5 in In distribution
G2G23316 Length 9 in In distribution
G2E901168 Length 2 in In distribution
G2N52295 Length 3 in In distribution
G2N52227 Length 3 in In distribution
G2N52552 In distribution
G2G2425 Length 6.25 in In distribution
G2G23160 Width 1.25 inches In distribution
G2N99539 Length 4.375 in In distribution
G2G23430 Length 13 in In distribution
G2G2443 Length 10.75 in In distribution
G2N52210 tip width 1 inches In distribution
G2G37008 Length 11 in In distribution
G2O917039 Length 11.75 in In distribution
G2N52298 Length 3 in In distribution
G2N99371 Length 7.5 in In distribution
G2G35854 Length 5.25 in In distribution
G2G37052 Length 75 mm In distribution
G2G24092 Length 7.5 in In distribution
G2N52565 Length 4 in In distribution
G2N52585 Length 8 in In distribution
G2G23130 Length 9.25 in In distribution
G2N52212 In distribution
G2G24130 Length 10 in In distribution
G2N52588 Length 9.5 in In distribution
G2N52216 Length 9 in In distribution
G2N52231 Length 5.5 in In distribution
G2N52529 Length 8.25 in In distribution
G2N52564 Length 3 in In distribution
G2N52541 Length 7.5 in In distribution
G2G37092 Length 8.5 in In distribution
G2G23150 Length.75 in In distribution
G2N52593 Length 8 in In distribution
G2N52217 Length 8.5 in In distribution
G2N52295 Length 3 in In distribution
G2N52592 Length 6.25 in In distribution
G2N52227 Length 3 in In distribution
G2G23440 Length 13 in In distribution
G2G24050 Length 7.5 in In distribution
G2N52543 Length 7.5 in In distribution
G2N52299 Length 3 in In distribution
G2N52102 Tip Length 1/4 inches In distribution
G2G23020 Length 6.25 in In distribution
G2N52102 Tip Length 1/4 inches In distribution
G2N99469 Length 7.5 in In distribution
G2N52583 Length 6.25 in In distribution
G2G23316 Length 9 in In distribution
G2N52215 Length 3 in In distribution
G2N52226 Length 4 in In distribution
G2N52584 Length 6.25 in In distribution
G2G37079 Length 7 in In distribution
G2N52250 Length 1 in In distribution
G2OB1621 Length 9.5 in In distribution
G2G2421 Length 8.75 in In distribution
G2N52104 Tip Width.25MM In distribution
G2N52401 Length 7 in In distribution
G2N99425 Length 5 in In distribution
G2N52309 Length 13 in In distribution
G2G23130 Length 9.25 in In distribution
G2N52227 Length 3 in In distribution
G2OB1605 Length 4.5 in In distribution
G2N52296 Length 3 in In distribution
G2G23470 Length 13 in In distribution
G2G36984 Length 8 in In distribution
G2G37006 Length 11 in In distribution
G2N52541 Length 7.5 in In distribution
G2N99471 Length 8.75 in In distribution
G2N52252 In distribution
G2G36977 Length 19 cm In distribution
G2G35941 Length 5.5 in In distribution
G2O7021 Length 10.75 in In distribution
G2N52277 Length 3 in In distribution
G2N99485 Length 5.125 in In distribution
G2N52236 Tip Width 1.25″ In distribution
G2G23310 Length 8.5 in In distribution
G2N99409 Length 5.25 in In distribution
G2G23110 Length 9.5 in In distribution
G2G23170 Length 1.5 in In distribution
G2N52229 Length 2 in In distribution
G2G35920 Length 7 in In distribution
G2G35898 tip width 40 mm In distribution
G2N52228 Length 4 in In distribution
G2N52209 tip width 0.625 inches In distribution
G2N52306 Length 3 in In distribution
G2N52297 Length 3 in In distribution
G2N52551 Length 4 in In distribution
G2N99408 Length 5.25 in In distribution
G2N52586 Length 8 in In distribution
G2G23450 Length 13 in In distribution
G2G37033 Length 6.25 in In distribution
G2G23180 Length 9.25 in In distribution
G2N52579 Length 4.5 in In distribution
G2N52307 Length 9.5 in In distribution
G2G23060 Length 7 in In distribution
G2N52587 Length 4.5 in In distribution
G2G23560 Length 8 in In distribution
G2G2434 Length 4 in In distribution
G2G23326 Length 12 in In distribution
G2N52233 Length 3.5 in In distribution
G2N52296 Length 3 in In distribution
G2N52298 Length 3 in In distribution
G2G2422 Length 8.75 in In distribution
G2N52211 tip width 2 inches In distribution
G2N52253 In distribution
G2N52552 In distribution
G2N99369 Length 11 in In distribution
G2OB1475 Length 36 mm In distribution
G2N52229 Length 2 in In distribution
G2N52230 Length 7.5 in In distribution
G2N52584 Length 6.25 in In distribution
G2G37279 Length 9.75 in In distribution
G2G23160 Width 1.25 inches In distribution
G2N52251 Length 1 in In distribution
G2N52579 Length 4.5 in In distribution
G2N52235 Length 6.5 in In distribution
G2G23950 Length 4.5 in In distribution
G2G23319 Length 12 in In distribution
G2N51379 In distribution
G2N52304 Length 3 in In distribution
G2G35720 In distribution
G2G24120 Length 10.675 in In distribution
G2OB1622 Length 90 mm In distribution
G2N99370 Length 7.5 in In distribution
G2E900952 Length 9 in In distribution
G2N52228 Length 4 in In distribution
G2N52591 Length 6.25 in In distribution
G2G23020 Length 6.25 in In distribution
G2G24130 Length 10 in In distribution
G2G37007 Length 11 in In distribution
G2N52256 Length 12 in In distribution
G2G23460 Length 13 in In distribution
G2G23010 Length 6.25 in In distribution
G2N52286 Length 11 in In distribution
G2E900947 Length 8 in In distribution
G2N52297 Length 3 in In distribution
G2N52529 Length 8.25 in In distribution
G2G23318 Length 10.5 in In distribution
G2N52550 Length 2.75 in In distribution
G2N99558 Length 7.5 in In distribution
G2G23328 Length 14.5 in In distribution
G2G24020 Length 6 in In distribution
G2N52232 Length 4.5 in In distribution
G2N52556 Length 2.75 in In distribution
G2O917096 Length 6.75 in In distribution
G2G35719 Length 174 mm In distribution
G2N99373 Length 9 in In distribution
G2N99446 Length 10.5 in In distribution
G2N99582 Tip Width 1″ In distribution
G2G23400 Length 10 in In distribution
G2G23270 Length 9.375 in In distribution
G2G35714 Length 60 mm In distribution
G2G23323 Length 12 in In distribution
G2G36048 Length 6 in In distribution
G2G37297 In distribution
G2G37032 Length 3.375 in In distribution
G2G23324 Length 12 in In distribution
G2G23570 Length 8 in In distribution
G2N52588 Length 9.5 in In distribution
G2N52306 Length 3 in In distribution
G2O917038 Length 11.75 in In distribution
G2G35898 tip width 40 mm In distribution
G2G23120 Length 9.25 in In distribution
G2N52544 Length 7.5 in In distribution
G2N52103 Tip Length 0.25 inches In distribution
G2G35899 tip width 60 mm In distribution
G2G37031 Length 4.125 in In distribution
G2N52566 Length 5 in In distribution
G2N99514 Length 7.3 mm In distribution
G2N51391 Length 40 mm In distribution
G2N99371 Length 7.5 in In distribution
G2N99515 Length 4.7 mm In distribution
G2G2441 Tip Length 7.5 cm In distribution
G2N52304 Length 3 in In distribution
G2G35711 Length 60 mm In distribution
G2N52299 Length 3 in In distribution
G2N52503 Length 6.87 in In distribution
G2N52585 Length 8 in In distribution
G2N52592 Length 6.25 in In distribution
G2G35717 Length 9 in In distribution
G2N52155 Length 13 mm In distribution
G2OB1604 In distribution
G2G23311 Length 6.5 in In distribution
G2G2432 Length 6 in In distribution
G2N52205 Length 2.25 in In distribution
G2N52401 Length 7 in In distribution
G2G37117 Length 7.75 in In distribution
G2G2420 Length 8.75 in In distribution
G2N52547 Length 4 in In distribution
G2N52103 Tip Length 0.25 inches In distribution
G2N52115 Length 9.5 in In distribution
G2N52130 Length 5 cm In distribution
G2E900950 Length 7 in In distribution
G2N99361 Length 4.25 in In distribution
G2OB1602 Length 385 mm In distribution
G2N52581 Length 5.5 in In distribution
G2N52211 tip width 2 inches In distribution
G2N52217 Length 8.5 in In distribution
G2N52106 Length 8 in In distribution
G2G35706 Tip Length 80 mm In distribution
G2OB1603 Length 3 in In distribution
G2N52580 Length 4 in In distribution
G2N52583 Length 6.25 in In distribution
G2G2429 Length 10 in In distribution
G2N52130 Length 5 cm In distribution
G2N52128 Length 3 cm In distribution
G2N52209 tip width 0.625 inches In distribution
G2G35916 tip width 2.5 inches In distribution
G2G2441 Tip Length 7.5 cm In distribution
G2N52273 Length 2 in In distribution
G2G23580 Length 8 in In distribution
G2E900951 Length 7 in In distribution
G2N52210 tip width 1 inches In distribution
G2G35709 Length 8 in In distribution
G2E900948 Length 5.5 in In distribution
G2N52309 Length 13 in In distribution
G2G23321 Length 13 in In distribution

Showing 250 of 258 catalogue numbers.

Same Product Code

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Product Sold by Catalogue numbers
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gSource Gsource, LLC. 753
Sklar® Sklar Corporation 753

Showing 12 of 2,238. All products under Retractor

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