P.P. BlueShaper Z3
- Primary DI
- 00810092939092
- Brand
- P.P. BlueShaper Z3
- Company
- NUSMILE, LTD.
- Model
- PP-144
- Device description
- 100 units
- Published
- 2022-07-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
nusmile.comProduct Codes
| Code | Name |
|---|---|
| EKN | Point, Paper, Endodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EKN | Point, Paper, Endodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00810092939092 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00810092939092 | 00810092939092 | 810092939092 | 0810092939092 |
GMDN Terms
| Term | Definition |
|---|---|
| Endodontic paper point | A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 832-540-5964 | plara@nusmile.com |
Regulatory Flags
- DUNS number
- 185497372
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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