FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613032715
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
421634J
Device description
"Valvulotome, Retrograde, Overall Length 9-1/2"" (241mm)"
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613032715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613032715001946130327151946130327150194613032715

GMDN Terms#

Term, Definition table
TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). 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
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389989DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219390220DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510062DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510086DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219511687DELACROIX-CHEVALIERLANDANGERDWS2026-07-04
03661219141440DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219143499DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266204DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266358DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266969DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
00884450376171One-Tie®Merit Medical Systems, Inc.DWS2026-06-06
00810220800324Adler Instrument CompanyAdler, Inc.DWS2026-06-02
00846159039931SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039948SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28