FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962119150
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-31-0962
Catalog number
HNM-1-31-0962
Device description
RND SPECULA
Published
2023-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXESpeculum, Non-Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962119150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962119150008429621191508429621191500842962119150

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

Regulatory Flags#

DUNS number
806754185
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
00812171026570HNM MEDICALHKW-11-090009HKW-11-0900092019-05-30
00812171026587HNM MEDICALHKW-11-090011HKW-11-0900112019-05-30
00812171026594HNM MEDICALHKW-11-090016HKW-11-0900162019-05-30
00812171026600HNM MEDICALHKW-11-090014HKW-11-0900142019-05-30
00812171026617HNM MEDICALHKW-11-060014HKW-11-0600142019-05-30
00812171026624HNM MEDICALHKW-11-120009HKW-11-1200092019-05-30
00812171026631HNM MEDICALHKW-13-090016HKW-13-0900162019-05-30
00812171026679HNM MEDICALHKW-11-040011HKW-11-0400112019-05-30
00812171026686HNM MEDICALHKW-11-040016HKW-11-0400162019-05-30
00812171026693HNM MEDICALHKW-11-040014HKW-11-0400142019-05-30
00812171026709HNM MEDICALHKW-11-050007HKW-11-0500072019-05-30
00812171026716HNM MEDICALHKW-11-090020HKW-11-0900202019-05-30
00812171026723HNM MEDICALHKW-11-090024HKW-11-0900242019-05-30
00812171026730HNM MEDICALHKW-11-090028HKW-11-0900282019-05-30
00812171026747HNM MEDICALHKW-11-090032HKW-11-0900322019-05-30
00812171026754HNM MEDICALHKW-11-090035HKW-11-0900352019-05-30
00812171026761HNM MEDICALHKW-11-090040HKW-11-0900402019-05-30
00812171026778HNM MEDICALHKW-11-090045HKW-11-0900452019-05-30
00812171026785HNM MEDICALHKW-15-090020HKW-15-0900202019-05-30
00812171026792HNM MEDICALHKW-15-090024HKW-15-0900242019-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158218888PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218178PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218185PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00810158214699PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00192896100671TEALES GORGET SPECULUMSONTEC INSTRUMENTS, INC.FXE2025-02-24
00190776390167MillenniumAvalign Technologies, Inc.FXE2024-05-31
G586N6867570Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867580Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867590Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867610Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
00190776041786AvalignAvalign Technologies, Inc.FXE2023-11-13
00192896115750Teales Gorget SpeculumSONTEC INSTRUMENTS, INC.FXE2023-11-03
00190776316471MILLENNIUMAvalign Technologies, Inc.FXE2023-09-28
G453333611190PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
G4533336204900PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
00842962137956HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137963HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137970HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
14026704792211PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
14026704792228PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792219PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792226PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
00842331180996Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14