FDA UDI
In Commercial Distribution
🇺🇸 United States
Burkhart Contra DPA W/Soft Cup, Teal (144)
DI: 00815878020803
·
Model: 72720836
·
BURKHART DENTAL SUPPLY CO., THE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
144
Basic Information
- Brand Name
- Burkhart Contra DPA W/Soft Cup, Teal (144)
- Primary DI
- 00815878020803
- Version / Model
- 72720836
- Company Name
- BURKHART DENTAL SUPPLY CO., THE
- Labeler DUNS
- 027532357
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2018-05-07
- Public Version
- 1
- Public Version Date
- 2018-06-07
- Public Version Status
- New
- Public Device Record Key
- 10385cc2-3852-4c0b-a87b-9e968b10d36f
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
- 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 | 10815878020800 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 00815878020803 | GS1 | ||||
| Unit of Use | 00815878020810 | GS1 |
Customer Contacts
- Phone
- 800-562-8176
- [email protected]