FDA.reportPublic FDA data

Realstar Surgical

Primary DI
00850071684254
Brand
Realstar Surgical
Company
REAL STAR SURGICAL INSTRUMENTS
Model
RSSI-130-150
Device description
Rigby Retractor
Published
2025-01-21
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
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071684254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071684254008500716842548500716842540850071684254

GMDN Terms#

Term, Definition table
TermDefinition
Post-parturition vaginal retractorA dedicated device intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g., suturing) of vaginal tears. It is a non-hinged, self-retaining retractor typically in the form of a polymer sheet/leaflet designed to be bent and inserted into the vagina whereby it self-expands to dilate the vaginal opening. This is a single-use 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
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
00850071684032Realstar SurgicalRSSI-130-220-902025-01-12
00850071684049Realstar SurgicalRSSI-130-225-902025-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440096Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440102Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440119Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440126Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440133Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440164Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440324Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440331Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440348Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440355Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440362Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440379Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26