FDA UDI
In Commercial Distribution
🇺🇸 United States
Beesure
DI: 10817508021607
·
Model: BE503T
·
ASCEND EAGLE INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
400
Basic Information
- Brand Name
- Beesure
- Primary DI
- 10817508021607
- Version / Model
- BE503T
- Company Name
- ASCEND EAGLE INCORPORATED
- Labeler DUNS
- 167102750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2022-05-23
- Public Version
- 1
- Public Version Date
- 2022-05-31
- Public Version Status
- New
- Public Device Record Key
- 45a2131e-d018-4b00-9844-0ff47e16c4ec
Device Description
Beesure Micro Applicators 400 /BX , Green Fine
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EJB | Handle, Instrument, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11171 | Denture repair kit, professional | A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817508021604 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10817508021607 | GS1 | ||||
| Unit of Use | 00817508021600 | GS1 |
Customer Contacts
- Phone
- 7075536190
- [email protected]