FDA.reportPublic FDA data

Laborde Dilator Forcep

Primary DI
G25010005140
Brand
Laborde Dilator Forcep
Company
N S SURGICAL COMPANY
Model
10-005-14
Catalog number
10-005-14
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.
Published
2023-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCGDilator, Tracheal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25010005140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, reusableA 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 Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Centimeter

Sterilization Methods#

Method table
Method
"[""Ultraviolet Light"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ultraviolet Light;Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (817) 7897257medrosurgical@gmail.com

Regulatory Flags#

DUNS number
645681649
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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G25012191240Lambotte Osteotomes Straight 38mm12-191-2412-191-242023-09-02
G25012195240Lambotte Osteotomes Curved 13mm12-195-2412-195-242023-09-02
G25003140150Debakey Forceps 1.5mm/15cm03-140-1503-140-152023-04-28
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G25009047190Anderson Retractor 19cm Blunt 4x409-047-1909-047-192023-04-28
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G25010034030Killian Nasal Speculum 75mm/13cm10-034-0310-034-032023-04-29
G25010035010Cottle Nasal Speculum 35mm/15cm10-035-0110-035-012023-04-29
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