FDA UDI
In Commercial Distribution
🇺🇸 United States
Cleaning Crystals, Packette
DI: 00816063021407
·
Model: 20127
·
Align Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Cleaning Crystals, Packette
- Primary DI
- 00816063021407
- Version / Model
- 20127
- Company Name
- Align Technology, Inc.
- Labeler DUNS
- 013831768
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 6c92cc84-e288-4b28-b5af-ef7388e7d08c
Device Description
Cleanser
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
- Yes
- 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 |
|---|---|---|---|---|
| EFT | Cleanser, Denture, Over The Counter | Dental | 872.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44736 | Orthodontic appliance cleanser | An agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816063021407 | GS1 | ||||
| Package | 00816063021162 | GS1 | 3 pack | 3 | In Commercial Distribution | |
| Package | 00816063020301 | GS1 | bulk 250 | 250 | In Commercial Distribution | |
| Package | 00816063020318 | GS1 | 50ct kit | 50 | In Commercial Distribution | |
| Package | 00816063021179 | GS1 | kit | 50 | In Commercial Distribution |