FDA.reportPublic FDA data

Realstar Surgical

Primary DI
00850071684032
Brand
Realstar Surgical
Company
REAL STAR SURGICAL INSTRUMENTS
Model
RSSI-130-220-90
Device description
Weisman Speculum 90° (Left Open), Large
Published
2025-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850071684032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071684032008500716840328500716840320850071684032

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
645842282
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071684308REALSTAR SURGICAL INSTRUMENTSRSSI-878-1912025-09-09
00850071684162Realstar SurgicalRSSI-130-1602025-01-21
00850071684179Realstar SurgicalRSSI-130-1752025-01-21
00850071684186Realstar SurgicalRSSI-130-1612025-01-21
00850071684193Realstar SurgicalRSSI-130-1762025-01-21
00850071684209Realstar SurgicalRSSI-130-1782025-01-21
00850071684216Realstar SurgicalRSSI-130-1792025-01-21
00850071684223Realstar SurgicalRSSI-130-1652025-01-21
00850071684230Realstar SurgicalRSSI-130-1352025-01-21
00850071684247Realstar SurgicalRSSI-130-1352025-01-21
00850071684254Realstar SurgicalRSSI-130-1502025-01-21
00850071684261Realstar SurgicalRSSI-130-1852025-01-21
00850071684278Realstar SurgicalRSSI-130-1862025-01-21
00850071684285Realstar SurgicalRSSI-130-1802025-01-21
00850071684292Realstar SurgicalRSSI-130-1812025-01-21
00860012999606Realstar SurgicalRSSI-130-1702025-01-21
00850071684001Realstar SurgicalRSSI-130-1122025-01-12
00850071684018Realstar SurgicalRSSI-130-1112025-01-12
00850071684025Realstar SurgicalRSSI-130-224-902025-01-12
00850071684049Realstar SurgicalRSSI-130-225-902025-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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