FDA UDI
In Commercial Distribution
🇺🇸 United States
Microbrush
DI: 00789594000381
·
Model: PR400PU
·
YOUNG MICROBRUSH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Microbrush
- Primary DI
- 00789594000381
- Version / Model
- PR400PU
- Catalog Number
- PR400PU
- Company Name
- YOUNG MICROBRUSH, LLC
- Labeler DUNS
- 929236305
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-08
- Public Version
- 6
- Public Version Date
- 2022-10-05
- Public Version Status
- Update
- Public Device Record Key
- 7b60eb16-b6de-49e4-92f6-77deb926a064
Device Description
Microbrush Disposable Micro-Applicators, M10 Regular 2.0mm, Purple
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KXR | APPLICATOR, RESIN | Dental | 872.3140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20789594000385 | GS1 | Case | 24 | In Commercial Distribution | |
| Package | 10789594000388 | GS1 | Tray | 400 | In Commercial Distribution | |
| Primary | 00789594000381 | GS1 |
Customer Contacts
- Phone
- +1 (866) 866-8698
- [email protected]