FDA UDI
In Commercial Distribution
🇺🇸 United States
Monoart
DI: E3072640030
·
Model: KIT MONOART DENTIST CHAIR COVER
·
EURONDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Monoart
- Primary DI
- E3072640030
- Version / Model
- KIT MONOART DENTIST CHAIR COVER
- Catalog Number
- 264003
- Company Name
- EURONDA SPA
- Labeler DUNS
- 428755441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-17
- Public Version
- 1
- Public Version Date
- 2019-12-25
- Public Version Status
- New
- Public Device Record Key
- 506bea6f-4c75-46e2-a304-f4bf2e3c894b
Device Description
A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: yellow
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
- 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
- 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 |
|---|---|---|---|---|
| NRU | Chair, Dental, Without Operative Unit | Dental | 872.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63712 | Medical equipment drape, single-use, non-sterile | A non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E3072640030 | HIBCC | ||||
| Package | E3072640032 | HIBCC | Kit | 3 | In Commercial Distribution | |
| Package | E3072640031 | HIBCC | Carton | 25 | In Commercial Distribution |