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
00841536147810ThompsonThompson Surgical Instruments, Inc.GAD2026-05-27
G453BH72800PEAK MEDICALPeak Medical Distribution Inc.GAD2026-03-30
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
08904332600681MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600629MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10
08800071700395Tiger View Kims Med Co.,Ltd.GAD2025-02-10
G141549052210Carnegie Surgical LLCCarnegie Surgical LLCGAD2025-01-17
08403207002334Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207002440Anmuth Medical InternationalAnmuth Medical International, LLCGAD2024-04-10
08403207131218Anmuth Medical InternationalAnmuth Medical International, LLCGAD2023-11-16