FDA.reportPublic FDA data

Sklar®

Primary DI
10649111392283
Brand
Sklar®
Company
SKLAR CORPORATION
Model
90-3061
Device description
WEISSBARTH STRAINER 4 VAG SPEC
Published
2018-09-24
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
10649111392283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911139228310649111392283

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
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111184420Sklar40-73182019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12
10649111229817Sklar Instruments96-11202025-11-12

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
10653160360216CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2023-05-19
10653160294153CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-02
10653160294122CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160294948CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160306528CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
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10381780495147Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-10-24
10649111392276Sklar®SKLAR CORPORATIONHDF2018-09-24
10381780500490Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500506Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
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10381780500582Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18
10381780500599Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18