FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613061395
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
571516J
Device description
"Laborde Dilator, Tri-Valve, Overall Length 5-1/2"" (140mm)"
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613061395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613061395001946130613951946130613950194613061395

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags#

DUNS number
556623486
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194613017279MSI Precision Specialty InstrumentsE53772025-08-01
00194613017286MSI Precision Specialty InstrumentsE53782025-08-01
00194613018993MSI Precision Specialty InstrumentsM134002025-08-01
00194613044572MSI Precision Specialty InstrumentsF94982025-08-01
00194613089696MSI Precision Specialty InstrumentsF94952025-08-01
00194613109684MSI Precision Specialty InstrumentsE53702025-08-01
00194613110772MSI Precision Specialty InstrumentsE53762025-08-01
00194613003845MSI Precision Specialty Instruments5-14452024-08-15
00194613044800MSI Precision Specialty Instruments17-13502024-08-15
00194613045173MSI Precision Specialty Instruments17-13302024-08-15
00194613045685MSI Precision Specialty Instruments2380182024-08-15
00194613046354MSI Precision Specialty Instruments17-13122024-08-15
00194613055332MSI Precision Specialty Instruments17-13102024-08-15
00194613018382MSI Precision Specialty Instruments52-20632025-08-01
00194613018504MSI Precision Specialty Instruments52-22612025-08-01
00194613018771MSI Precision Specialty Instruments51-23012025-08-01
00194613018788MSI Precision Specialty Instruments51-25012025-08-01
00194613018856MSI Precision Specialty Instruments51-19012025-08-01
00194613020873MSI Precision Specialty Instruments51-20012025-08-01
00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407721749FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721756FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721770FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407721794FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721831FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407721879FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721916FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721923FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722036FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722043FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722050FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722067FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722388FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722395FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722401FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722418FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722425FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722432FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722456FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722463FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722470FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722487FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722494FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722500FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722517FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722524FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722531FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722548FENTEXFENTEX medical GmbHLRC2022-12-09