FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613109899
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
40-3490
Device description
"Calcaneal Spreader, 6mm Serrated Blade, Maximum Diameter 0.51"" (1.3mm), 1-1/4"" Opening, Overall Length 3-3/4"" (95mm)"
Published
2025-03-21
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613109899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613109899001946131098991946131098990194613109899

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268567Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268574Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23