Sparkle™ Prophy Angle
GUDID 50732224002922
Prophy Angles, Soft Cup, Purple
CROSSTEX INTERNATIONAL, INC.
Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use Dental polishing cup, single-use| Primary Device ID | 50732224002922 |
| NIH Device Record Key | d89f5aef-ff2d-406a-8bed-3585a1b83f10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sparkle™ Prophy Angle |
| Version Model Number | TPASSC1 |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224002927 [Unit of Use] |
| GS1 | 10732224002924 [Primary] |
| GS1 | 50732224002922 [Package] Contains: 10732224002924 Package: [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| EFA | Handpiece, belt and/or gear driven, dental |
| EGS | Handpiece, contra- and right-angle attachment, dental |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
On-Brand Devices [Sparkle™ Prophy Angle]
| 50732224002953 | Prophy Angles, Soft Cup, Purple |
| 50732224002946 | Prophy Angles, Disposable, Firm Cup White |
| 50732224002939 | Prophy Angle,Tapered Brush |
| 50732224002922 | Prophy Angles, Soft Cup, Purple |
| 50732224002915 | Prophy Angle, Firm Cup, White |
Trademark Results [Sparkle]
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