FDA UDI
In Commercial Distribution
🇺🇸 United States
OMNISLEEVE
DI: 08056646502561
·
Model: 22.U0001.00
·
OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OMNISLEEVE
- Primary DI
- 08056646502561
- Version / Model
- 22.U0001.00
- Company Name
- OMNIA SRL
- Labeler DUNS
- 447696675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-23
- Public Version
- 3
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 0e6da818-2419-4817-9c28-449e571a1d0a
Device Description
sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056646502561 | GS1 | ||||
| Package | 08056646502578 | GS1 | 100 | In Commercial Distribution |