FDA.reportPublic FDA data

J&J Instruments

Primary DI
00817524027600
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
39-5195
Catalog number
39-5195
Device description
PEDERSON VAGINAL SPEC X-NARROW
Published
2023-03-01
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
00817524027600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524027600008175240276008175240276000817524027600

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
783328149
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524027846J&J Instruments42-123042-12302023-03-01
00817524027853J&J Instruments42-127042-12702023-03-01
00817524022865J&J Instruments07-2002019-10-07
00817524020328J & J INSTRUMENTS02-010 02-010 2018-05-31
00817524020335J & J INSTRUMENTS02-02002-0202018-05-31
00817524020359J & J INSTRUMENTS02-10102-1012018-05-31
00817524020397J & J INSTRUMENTS02-275 02-275 2018-05-31
00817524020403J & J INSTRUMENTS02-28502-2852018-05-31
00817524020410J & J INSTRUMENTS02-28602-2862018-05-31
00817524020427J & J INSTRUMENTS02-28702-2872018-05-31
00817524020434J & J INSTRUMENTS02-28802-2882018-05-31
00817524020441J & J INSTRUMENTS02-29102-2912018-05-31
00817524020458J&J Instruments02-292 02-292 2018-10-16
00817524020465J&J Instruments02-293 02-293 2018-10-16
00817524020472J&J Instruments02-294 02-294 2018-10-16
00817524020489J&J Instruments02-295 02-295 2018-10-16
00817524020496J&J Instruments02-296 02-296 2018-10-16
00817524020618J & J INSTRUMENTS INC02-50002-5002018-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10653160294153CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-02
10653160294122CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160294948CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160306528CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
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
10649111392276Sklar®SKLAR CORPORATIONHDF2018-09-24
10649111392283Sklar®SKLAR CORPORATIONHDF2018-09-24
10381780500490Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500506Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500513Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500520Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500537Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500544Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500551Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500582Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500599Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18