FDA UDI
In Commercial Distribution
🇺🇸 United States
REALSTAR SURGICAL INSTRUMENTS
DI: 00850071684308
·
Model: RSSI-878-191
·
REAL STAR SURGICAL INSTRUMENTS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REALSTAR SURGICAL INSTRUMENTS
- Primary DI
- 00850071684308
- Version / Model
- RSSI-878-191
- Company Name
- REAL STAR SURGICAL INSTRUMENTS
- Labeler DUNS
- 645842282
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- 11aac8af-582b-47db-9aaa-3788a3811341
Device Description
SMOKE EVACUATOR TUBING FOR LEEP AND LASER VAGINAL SPECULA Specula Accessory
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXG | Specula Accessories | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46483 | Surgical plume evacuation system tube | A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850071684308 | GS1 |