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
Primary DIBrandCompanyProduct codePublished
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
00198506093852ELMEDELMED INCORPORATEDHDF2026-07-29
00198506093142ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093265ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093272ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038120Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915039110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471000Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471130Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471140Surgical DirectSurgical Direct, Inc.HDF2026-07-28
00190776421939MillenniumAvalign Technologies, Inc.HDF2026-07-23
00198506091964ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506091995ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506092008ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506091803ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091827ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091834ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00850083275365Intrace USAPILOTIS TECH LLCHDF2026-07-03
00190776421632MillenniumAvalign Technologies, Inc.HDF2026-06-23
00810158211360PRINCETONPrinceton Medical Group, Inc.HDF2026-06-23
05060212052339Cusco Specula Metal SmallDTR MEDICAL LIMITEDHDF2026-06-10
05060212052346Cusco Specula Metal MediumDTR MEDICAL LIMITEDHDF2026-06-10
05060212052360Cusco Specula Metal LargeDTR MEDICAL LIMITEDHDF2026-06-10
05060411982314Cusco Specula Metal Large LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982321Cusco Specula Metal Large Extra LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982369Cusco Specula Metal BroadDTR MEDICAL LIMITEDHDF2026-06-10
05060411984462Cusco Specula Metal Medium LongDTR MEDICAL LIMITEDHDF2026-06-10