FDA.reportPublic FDA data

Galaxy II Surgical Retractor

Primary DI
15060557440164
Brand
Galaxy II Surgical Retractor
Company
MOSAIC SURGICAL LIMITED
Model
JUNEGX-2020
Device description
Galaxy II Male Kit
Published
2026-03-26
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
15060557440164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506055744016415060557440164

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, single-useA sterile, frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a single-use device.

Regulatory Flags#

DUNS number
222357455
Device count
1
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
65060557440053Galaxy II Surgical RetractorJUNE3002b-82026-04-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
B382SD907234170Surgical DirectSurgical Direct, Inc.FFO2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776436773MillenniumAvalign Technologies, Inc.HDL2026-10-21
00724995275235V. MuellerSTERIS Deutschland GmbHKAL2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00724995328788V. MuellerSTERIS Deutschland GmbHKAL2026-10-21
00840338612656Made-To-OrderTORNIER, INC.GAD2026-10-21
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