FDA UDI
In Commercial Distribution
🇺🇸 United States
Suction set 2.20 m with terminal cannula Omniasp and autologous bone filterl
DI: 08052141312230
·
Model: 32.F7077.00
·
OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Suction set 2.20 m with terminal cannula Omniasp and autologous bone filterl
- Primary DI
- 08052141312230
- Version / Model
- 32.F7077.00
- Company Name
- OMNIA SRL
- Labeler DUNS
- 447696675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 1
- Public Version Date
- 2023-07-03
- Public Version Status
- New
- Public Device Record Key
- bb7880cf-7023-41f4-9c84-92640711a47d
Device Description
Suction set 2.20 m with terminal cannula Omniasp and autologous bone filter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EBR | Unit, Suction Operatory | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. 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 | 08052141312247 | GS1 | ||||
| Primary | 08052141312230 | GS1 |