FDA UDI
In Commercial Distribution
🇺🇸 United States
Galaxy II Surgical Retractor
DI: 15060557440126
·
Model: JUNE3000
·
MOSAIC SURGICAL LIMITED
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Galaxy II Surgical Retractor
- Primary DI
- 15060557440126
- Version / Model
- JUNE3000
- Company Name
- MOSAIC SURGICAL LIMITED
- Labeler DUNS
- 222357455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-03-26
- Public Version
- 1
- Public Version Date
- 2026-04-03
- Public Version Status
- New
- Public Device Record Key
- 5480b8dc-1cbe-4205-9619-3a5e8bad6bb1
Device Description
Galaxy II Snowman Frame
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | 876.4730 | 1 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | 884.4520 | 1 |
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
| KAL | Retractor, Ent | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47822 | Surgical retraction system mounting frame, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060557440126 | GS1 | ||||
| Unit of Use | 05060557440129 | GS1 |