FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040060169
·
Model: 1023448
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1000
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040060169
- Version / Model
- 1023448
- Catalog Number
- 1023448
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- ec8a7731-2b3f-4e23-8f59-b76e951a95cf
Device Description
Disposable Prophy Angle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46938 | Dental polishing cup, single-use | A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040060166 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 10304040060169 | GS1 | ||||
| Unit of Use | 00304040060162 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 49 Degrees Celsius