FDA.reportPublic FDA data

Galaxy II Surgical Retractor

Primary DI
45060557440059
Brand
Galaxy II Surgical Retractor
Company
MOSAIC SURGICAL LIMITED
Model
JUNE3002b-50
Device description
Galaxy II 5mm Blunt Individual Stays –Box of 50
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
45060557440059PrimaryGS10
05060557440051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4506055744005945060557440059
05060557440051050605574400515060557440051

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
50
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
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
15060557440119Galaxy II Surgical RetractorJUNE3001b122026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775585Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775592Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775608Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775615Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775622Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775639Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775646Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775653Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775660Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775677Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775684Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775691Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775707Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775714Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776872Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776889Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776896Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776902Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04