Laborde Dilator Forcep

A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a…

Registry build 21.09.26

A hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. This is a reusable device.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code KCG
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Laborde Dilator Forcep
Listed by N S Surgical Company
FDA product code KCG
Device type Dilator, Tracheal
Device class Class 1
Regulation 21 CFR 874.4420
Premarket notification Exempt
Record published 2023-04-29
Record revised 2023-05-31 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ultraviolet Light, Ethylene Oxide, Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
Sizes Length 14 cm

Catalogue Numbers

Catalogue numbers for Laborde Dilator Forcep
Catalogue number Size Status
10-005-14 Length 14 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pilling Teleflex Medical LLC 22
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Sklar Sklar Corporation 4
Millennium Avalign Technologies, Inc. 3
Boss Instruments Boss Instruments, Ltd. 3
Symmetry Trousseau Aspen Surgical Products, Inc. 3
Integra® Jarit® Integra LifeSciences Production Corporation 3
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 3
Trousseau Tracheal Dilator Retractor Sontec Instruments, Inc. 3

Showing 12 of 26. All products under Dilator, Tracheal

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