FDA UDI
In Commercial Distribution
🇺🇸 United States
SURG-E-VAC SMOKE EVACUATION SYSTEM
DI: 00841494106799
·
Model: SVF1
·
Cynosure, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SURG-E-VAC SMOKE EVACUATION SYSTEM
- Primary DI
- 00841494106799
- Version / Model
- SVF1
- Catalog Number
- SVF1
- Company Name
- Cynosure, LLC
- Labeler DUNS
- 780318028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-01-11
- Public Version Status
- Update
- Public Device Record Key
- 4ec0c5e0-0e99-4eff-9747-2c4d1ebd790e
Device Description
QUAD FILTER FOR SVD 7/8" DIAMETER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FYD | APPARATUS, EXHAUST, SURGICAL | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44979 | Surgical plume evacuation system filter | A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841494106799 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983333 | 000 |