FDA.reportPublic FDA data

Galaxy II Surgical Retractor

Primary DI
15060557440126
Brand
Galaxy II Surgical Retractor
Company
MOSAIC SURGICAL LIMITED
Model
JUNE3000
Device description
Galaxy II Snowman Frame
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
15060557440126PrimaryGS10
05060557440129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506055744012615060557440126
05060557440129050605574401295060557440129

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, single-useA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a single-use device.

Regulatory Flags#

DUNS number
222357455
Device count
10
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
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683363220Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683439140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-24
B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685612810Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255120Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685612550Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-07-23
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13