FDA.reportPublic FDA data

MSI Precision Specialty Instruments

Primary DI
00194613106980
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
611259J-I
Device description
"Steiner-Auvard Vaginal Speculum, Insulated, 2-1/2lb, Blade 1-1/4"" x 5-1/2"""
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194613106980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613106980001946131069801946131069800194613106980

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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
00198506091803ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091827ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091834ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00850083275365Intrace USAPILOTIS TECH LLCHDF2026-07-03
00190776421632MillenniumAvalign Technologies, Inc.HDF2026-06-23
00810158211360PRINCETONPrinceton Medical Group, Inc.HDF2026-06-23
05060212052339Cusco Specula Metal SmallDTR MEDICAL LIMITEDHDF2026-06-10
05060212052346Cusco Specula Metal MediumDTR MEDICAL LIMITEDHDF2026-06-10
05060212052360Cusco Specula Metal LargeDTR MEDICAL LIMITEDHDF2026-06-10
05060411982314Cusco Specula Metal Large LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982321Cusco Specula Metal Large Extra LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982369Cusco Specula Metal BroadDTR MEDICAL LIMITEDHDF2026-06-10
05060411984462Cusco Specula Metal Medium LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411985117Cusco Specula Metal Small XXLongDTR MEDICAL LIMITEDHDF2026-06-10
00198506091490ELMED INCORPORATEDELMED INCORPORATEDHDF2026-06-09
10649111067235Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111067624Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111068966Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069345Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069574Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069888Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
G586OB631721NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB631723NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB633804NC0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
10381780495024Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10381780495031Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10381780495048Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10381780495055Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10381780495062Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10381780495147Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24