FDA UDI
In Commercial Distribution
🇺🇸 United States
Galaxy II Surgical Retractor
DI: 25060557440062
·
Model: JUNE3003b-100
·
MOSAIC SURGICAL LIMITED
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Galaxy II Surgical Retractor
- Primary DI
- 25060557440062
- Version / Model
- JUNE3003b-100
- Company Name
- MOSAIC SURGICAL LIMITED
- Labeler DUNS
- 222357455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- 11745a4f-558c-401f-b696-ea933df415c2
Device Description
Galaxy II 12mm Blunt Individual Stays –Box 0f 100
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 |
|---|---|---|---|---|
| KAL | Retractor, Ent | Ear, Nose, Throat | 874.4420 | 1 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | 884.4520 | 1 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | 876.4730 | 1 |
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47821 | Surgical retractor/retraction system blade, single-use | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05060557440068 | GS1 | ||||
| Primary | 25060557440062 | GS1 |