FDA UDI
In Commercial Distribution
🇺🇸 United States
Galaxy II Surgical Retractor
DI: 15060557440317
·
Model: LClip4000
·
MOSAIC SURGICAL LIMITED
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Galaxy II Surgical Retractor
- Primary DI
- 15060557440317
- Version / Model
- LClip4000
- Company Name
- MOSAIC SURGICAL LIMITED
- Labeler DUNS
- 222357455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- 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
- a41ec4b8-2e4a-44e0-82d1-0b0c36f946ce
Device Description
Galaxy II LUX Clip
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 |
|---|---|---|---|---|
| 62137 | Medical/surgical interventional tube/cable securement clip, single-use | A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05060557440310 | GS1 | ||||
| Primary | 15060557440317 | GS1 |