FDA UDI
In Commercial Distribution
🇺🇸 United States
Operio
DI: 07350101640005
·
Model: Mobile
·
Toul Meditech AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Operio
- Primary DI
- 07350101640005
- Version / Model
- Mobile
- Company Name
- Toul Meditech AB
- Labeler DUNS
- 427895198
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-08
- Public Version
- 2
- Public Version Date
- 2020-10-06
- Public Version Status
- Update
- Public Device Record Key
- 074ac082-2f53-47ed-9f1d-23a928007f7c
Device Description
Operio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which produces a directed, non-turbulent ultraclean air flow to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| ORC | Air Filter Portable Apparatus | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36138 | Surgical laminar airflow unit | An electrically-powered device designed to filter air [usually through a high-efficiency particulate air (HEPA) filter] in surgical theatres by producing a directed, non-turbulent flow of clean air to provide an area free of contaminants and reduce the risk of patient infection. It may be mobile (on wheels) or fixed [e.g., to the ceiling], and provides a curtain of fast moving air that helps to delineate the sterile field; some types allow connection of a hose with a nozzle designed to be adhered to the patient to direct the filtered air across the surgical site. An operating light or light system may be mounted to this unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350101640005 | GS1 |