FDA.reportPublic FDA data

Realstar Surgical

Primary DI
00850071684261
Brand
Realstar Surgical
Company
REAL STAR SURGICAL INSTRUMENTS
Model
RSSI-130-185
Device description
Tissue Forceps, 20 cm
Published
2025-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HDAForceps, Obstetrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDAForceps, ObstetricalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071684261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071684261008500716842618500716842610850071684261

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

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
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
00190776419196MillenniumAvalign Technologies, Inc.HDA2026-04-13
00190776416119MillenniumAvalign Technologies, Inc.HDA2026-02-06
00190776409708MillenniumAvalign Technologies, Inc.HDA2025-09-08
00194613119683MSI Precision Specialty InstrumentsMed Saver, Inc.HDA2025-08-01
00190776406271MillenniumAvalign Technologies, Inc.HDA2025-07-21
00850071684278Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684285Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684292Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00190776387969MillenniumAvalign Technologies, Inc.HDA2024-11-12
00190776387075MillenniumAvalign Technologies, Inc.HDA2024-09-06
00190776384883MillenniumAvalign Technologies, Inc.HDA2024-08-26
00887482030196Symmetry AuvardASPEN SURGICAL PRODUCTS, INC.HDA2024-08-07
00887482043585Symmetry DeLeeASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482043615Symmetry Kielland-LuikartASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078877Symmetry ElliotASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078914Symmetry KiellandASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078976Symmetry BartonASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00840183505509BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00840183513344BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00190776127640MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776142698MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776143886MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776250744AvalignAvalign Technologies, Inc.HDA2023-11-13
00190776250089AvalignAvalign Technologies, Inc.HDA2023-09-28
00190776296797MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00190776371241MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00810123206148Adler Instrument CompanyAdler, Inc.HDA2023-08-24
00190776369125MillenniumAvalign Technologies, Inc.HDA2023-04-03
00840319750346Hayden MedicalHayden Medical, Inc.HDA2023-03-21
00840319750353Hayden MedicalHayden Medical, Inc.HDA2023-03-21