Celluleaf

Celluleaf - Surgical tool for subcutaneous blunt release of fibrous septae in soft tissues. The device is delivered sterile and intended for single use.

Registry build 21.09.26
14manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (4), Shanghai (3), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDI
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19

Showing 12 of 14. All 14 manufacturers in China registered for Dissector, Surgical, General & Plastic Surgery

Record

Regulatory record for Celluleaf
Listed by Aliform B.V., Netherlands
FDA product code GDI
Device type Dissector, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-06-17
Record revised 2025-09-10 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Storage Storage environment temperature 15 to 25 °C; Storage environment humidity 15 to 60 % RH
Packaging Pack of 4

Catalogue Numbers

Catalogue numbers for Celluleaf
Catalogue number Size Status
CELL001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lazic Peter Lazic Gmbh 154
Gimmi Gimmi Gmbh 129
Life Instruments Life Instrument Corp. 103
Ambler Surgical Ambler Surgical, LLC 90
Aesculap Aesculap AG 84
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 68
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 68
Boss Instruments Boss Instruments, Ltd. 67
Marina Medical Marina Medical Instruments, Inc. 59
Hayden Medical Hayden Medical Inc 57
Assi Accurate Surgical & Scientific Instruments Corp. 55
MSI Precision Specialty Instruments MED Saver, Inc. 48

Showing 12 of 214. All products under Dissector, 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