FDA UDI
In Commercial Distribution
🇺🇸 United States
iSmile
DI: 00816419021969
·
Model: 45-0009
·
Ismile Dental Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- iSmile
- Primary DI
- 00816419021969
- Version / Model
- 45-0009
- Catalog Number
- 45-0009
- Company Name
- Ismile Dental Products, Inc.
- Labeler DUNS
- 016765988
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2023-06-21
- Public Version
- 1
- Public Version Date
- 2023-06-29
- Public Version Status
- New
- Public Device Record Key
- e8cf69b9-b945-4606-9c0c-c079c59bdf6d
Device Description
Handpiece Sleeve 1" x 8" Clear
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A 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 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 20816419021963 | GS1 | ||||
| Primary | 00816419021969 | GS1 |
Customer Contacts
- Phone
- 916-928-0359
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190484 | 000 |