Laborde Dilator Forcep

Basic Information

• Brand Name: Laborde Dilator Forcep
• Primary DI: G25010005140
• Version / Model: 10-005-14
• Catalog Number: 10-005-14
• Company Name: N S SURGICAL COMPANY
• Labeler DUNS: 645681649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-29
• Public Version: 2
• Public Version Date: 2023-05-31
• Public Version Status: Update
• Public Device Record Key: 44aa8a8b-0721-476e-8213-a23b725e1773

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ultraviolet Light", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCG	Dilator, Tracheal	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11263	Tracheal surgery dilator, reusable	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G25010005140	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	14	Centimeter