FDA.reportPublic FDA data

Galaxy II Surgical Retractor

Primary DI
65060557440053
Brand
Galaxy II Surgical Retractor
Company
MOSAIC SURGICAL LIMITED
Model
JUNE3002b-8
Device description
Galaxy II 5mm Blunt Stays –Packs of 8
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining
GADRetractor
HDLRetractor, Vaginal
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1
GADRetractorGeneral, Plastic Surgery1
HDLRetractor, VaginalObstetrics/Gynecology1
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
65060557440053PrimaryGS10
85060557440057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6506055744005365060557440053
8506055744005785060557440057

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, single-useA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

Regulatory Flags#

DUNS number
222357455
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060557440317Galaxy II Surgical RetractorLClip40002026-04-09
15060557440423Galaxy II Surgical RetractorGX102026-04-09
15060557440430Galaxy II Surgical RetractorGX202026-04-09
15060557440447Galaxy II Surgical RetractorGX302026-04-09
15060557440454Galaxy II Surgical RetractorGX402026-04-09
25060557440062Galaxy II Surgical RetractorJUNE3003b-1002026-04-09
25060557440147Galaxy II Surgical RetractorJUNE3004s-502026-04-09
25060557440154Galaxy II Surgical RetractorJUNE3005b-502026-04-09
45060557440066Galaxy II Surgical RetractorJUNE3003b-502026-04-09
65060557440060Galaxy II Surgical RetractorJUNE3003b-82026-04-09
15060557440300Galaxy II Surgical RetractorJUNE3002sb-502026-04-02
15060557440393Galaxy II Surgical RetractorJUNE3002sb-82026-04-02
25060557440055Galaxy II Surgical RetractorJUNE3002b-1002026-04-02
45060557440059Galaxy II Surgical RetractorJUNE3002b-502026-04-02
15060557440003Galaxy II Surgical RetractorJUNE3000s52026-03-26
15060557440072Galaxy II Surgical RetractorJUNE3000b52026-03-26
15060557440089Galaxy II Surgical RetractorJUNE3000b122026-03-26
15060557440096Galaxy II Surgical RetractorJUNE3001s52026-03-26
15060557440102Galaxy II Surgical RetractorJUNE3001b52026-03-26
15060557440119Galaxy II Surgical RetractorJUNE3001b122026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00810111228480RetractorTreace Medical Concepts, Inc.GAD2026-10-16
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
B382SD48800050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
B382SD717510050Surgical DirectSurgical Direct, Inc.FFO2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14