Scalpel, One-Piece

Who Makes This Device Type in China?

14 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Zhejiang and Guangdong, and 3 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Anhui Yixiang Trading Co., Ltd. Anhui
Boen Healthcare Co., Ltd. Jiangsu
GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
Guangdong Comfort Medical Products Co., Ltd. Guangdong
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Huaian Angel Medical Instrument Co., Ltd. Jiangsu
Ningbo Medsun Medical Co., Ltd. Zhejiang, contract manufacturer
Nanjing J SUN Healthcare Co., Ltd. Jiangsu
Shanghai Hua En Industrial Co Ltd Shanghai, contract manufacturer
Sterilance Medical (Suzhou) Inc. Jiangsu, contract manufacturer
Suzhou Meccan Import and Export Corp. Jiangsu, contract manufacturer
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Guangdong, contract manufacturer
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Shandong, contract manufacturer
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code GDX?

Scalpel, One-Piece is FDA product code GDX, Class 1, 21 CFR 878.4800.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Packaging process control (4), Process control (1) and Packaging (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Scalpel, One-Piece

PMI

PMI Extractor-EZ is a disposable instrument with a retractable blade designed to enlarge the fascial opening

Scalpel, One-Piece

Scalpel, ONE-Piece

Catalogue number 1512, 1510, 1515, listed by Jhk, Inc., under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

V. Mueller

RHOTON STRAIGHT POINT NEEDLE NO 12, SEMI-SHARP OVERALL LENGTH 7-1/2 inches19.1CM

Scalpel, One-Piece

Index Asurity Disposable Safety Scalpel

Catalogue number 22-0422, listed by Sterilance Medical (Suzhou) Inc., China, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Scalpel Handle

Catalogue number 1UI015A, listed by I.T.S. Gmbh, Austria, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Devon

Scalpel

Scalpel, One-Piece

C Safe

C SAFE Safety Scalpel

Scalpel, One-Piece

MSI Precision Specialty Instruments

Mini Scalpel Size 11P Disposable Non-Sterile, 100 per Box

Scalpel, One-Piece

C35-Scalpel Accessory Tool

Catalogue number C35-SAT-2, listed by Medica Corp., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Bard

2 catalogue numbers from RM0752754, listed by Sterilance Medical (Suzhou) Inc., China, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Mastel Precision Surgical Instruments, Inc.

President EconoLance Trunc. (Econo Meister), Groover

Scalpel, One-Piece

Epimed International, Inc.

Racz NeuroStat RF Generator-4 Lesion

Scalpel, One-Piece

Devon

Scalpel #11

Scalpel, One-Piece

STERiLANCE

Catalogue number "Index Asurity SS#15 ", listed by Sterilance Medical (Suzhou) Inc., China, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Kiato

Kiato Sterile Disposable Scalpel Stainless Steel box of 10 size 11P. Sterilized using ethylene oxide.

Scalpel, One-Piece

Sureglide

Sureglide Safety Scalpel

Scalpel, One-Piece

Scalpel

Lateral release instrument machined - flat handle

Scalpel, One-Piece

Gimmi

Inzision Pick Alphadur System - Pediatric Version -

Scalpel, One-Piece

VertebraLINK MI

Bayonetted Scalpel Handle

Scalpel, One-Piece

PenBlade

#11P Safety Scalpel, Sterile

Scalpel, One-Piece

Medline Industries, Inc.

Scalpel NO.11 Safety Lock

Scalpel, One-Piece

Bard-Parker ® Disposable Mini-Scalpels

Catalogue number 371641, listed by Aspen Surgical Products, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

MediChoice

Scalpel Surgical Safety Fixed Blade With Movable Sheath Stainless Steel Size 15 Disposable Sterile Not Made With Natural Rubber Latex MediChoice

Scalpel, One-Piece

Shard

SHARD Disposable Premium Surgical Stainless Blades, Sterile. Size 15-C.

Scalpel, One-Piece

Reli

RELI® #11US Disposable Mini Scalpel SS, Bulk, Non-Sterile, 100EA/BG, 15BG/CS

Scalpel, One-Piece

Feather Disposable Scalpel Mini

3 catalogue numbers from No.11MINI, listed by Feather Safety Razor Co., Ltd., Japan, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Medi-Cut Disposable Scalpels, With Safety Guard, Stainless Steel Blades Size 12

8 catalogue numbers from 4112, listed by Dynarex Corp., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

GuideBlade

GuideBlade, non-sterile, intended for inclusion in kits

Scalpel, One-Piece

Kendall

Scalpel #10

Scalpel, One-Piece

Kendall

Scalpel

Scalpel, One-Piece

Integra® Miltex®

Integra® Miltex® Stainless Steel Disposable Safety Scalpels, No. 15C

Scalpel, One-Piece

Index Asurity

6 catalogue numbers from Index Asurity 3# SS 13#, listed by Sterilance Medical (Suzhou) Inc., China, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Kiato Plus

KIATO Plus Sterile Safety Scalpel Stainless Steel Box of 10 size 12d. Sterilized using ethylene oxide.

Scalpel, One-Piece

Cutfix

CUTFIX Disposable Scalpel, polymer handle, Fig. 21, stainless steel, sterile, disposable, package of 10 pieces

Scalpel, One-Piece

Scalpel, One-Piece

ACL GRAFT KNIFE 10mm

Scalpel, One-Piece

Medicon

Dieffenbach scalpel 16cm fig 4

Scalpel, One-Piece

Feather Disposable Scalpel Safeshield Scalpel

12 catalogue numbers from No.15, listed by Feather Safety Razor Co., Ltd., Japan, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

PenBlade Safety Scalpel

The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

Scalpel, One-Piece

Henry Schein

Scalpels Disposable Sterile

Scalpel, One-Piece

P&P Medical Surgical LLC

Disposable Safety Scalpels Sterile Surgical Blade Size 11 Stainless Steel with Plastic Handle & Metric Line Individually Foil Wrapped Box of 10

Scalpel, One-Piece

Bard-Parker ® Disposable Scalpels

13 catalogue numbers from 371615, listed by Aspen Surgical Products, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

T2 Alpha

Locking Scalpel

Scalpel, One-Piece

Medline

Scalpel, Safety, Disposable, Sterile, 10

Scalpel, One-Piece

Feather Disposable Scalpel

14 catalogue numbers from No.12d, listed by Feather Safety Razor Co., Ltd., Japan, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Medi-Cut Safety Scalpel

Medi-Cut Safety Scalpel, Sterile, # 15

Scalpel, One-Piece

Aesculap

Scalpel, 6 1/2", (165 mm), polymer handle, Fig. 67, stainless steel, yellow, sterile, disposable, package of 5 pieces

Scalpel, One-Piece

DeRoyal

Minor Thumb Disposable Scalpel

Scalpel, One-Piece

Sklar®

Sklarsafe Scalpel BX10 STR #11

Scalpel, One-Piece

Bard-Parker ® Safety Scalped

19 catalogue numbers from 372612, listed by Aspen Surgical Products, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Surgistar, Inc.

11 catalogue numbers from 126-MINDE-1AD, listed by Surgistar, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Lumohs

Illuminated Single-Use Scalpel, #10R Blade – White LED

Scalpel, One-Piece

McKesson

Safety Scalpels WITH PROTECTIVE SHEATH STAINLESS STEEL BLADE - DISPOSABLE - STERILE #15

Scalpel, One-Piece

Hexa

Disposable Stainless Steel Scalpels #10 10/Box

Scalpel, One-Piece

Sandel

NON-Weighted Safety Scalpel, #15 Blade, Bulk (NS)

Scalpel, One-Piece

Surgistar

142 catalogue numbers from 8521, listed by Surgistar, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.

Scalpel, One-Piece

Medi-Cut Safety Scalpel, With Disposal Lock, Retractable # 11

Size #10

Scalpel, One-Piece

Swann Morton Ltd.

A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue.…

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