FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158218062
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
47120-50SB
Device description
"SPECULA KILLIAN 50MM WITH SET SCREW BLACK COATED 5 1/8"""
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810158218062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158218062008101582180628101582180620810158218062

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
012857277
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
00810158219762PRINCETON11116-182026-05-20
00810158219779PRINCETON19995-382026-05-20
00810158219786PRINCETON89139-172026-05-20
00810158219793PRINCETON33654-102026-05-20
00810158219809PRINCETON45206-162026-05-20
00810158219816PRINCETON47471-042026-05-20
00810158219748PRINCETON45350-702026-05-19
00810158219755PRINCETON34533-172026-05-19
00810158219625PRINCETON25407-122026-04-22
00810158219687PRINCETON45706-352026-04-22
00810158219694PRINCETON45766-352026-04-22
00810158219700PRINCETON45766-402026-04-22
00810158219717PRINCETON45766-452026-04-22
00810158219724PRINCETON45766-502026-04-22
00810158219731PRINCETON75600-132026-04-22
00810158214538PRINCETON43602-032026-04-21
00810158219465PRINCETON11304-172026-04-21
00810158219472PRINCETON61025-202026-04-21
00810158219489PRINCETON61037-202026-04-21
00810158219496PRINCETON47223-022026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10653160294153CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-02
10653160294122CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160294948CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
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