FDA UDI
In Commercial Distribution
🇺🇸 United States
Beesure
DI: 10817508021379
·
Model: BE714SSP
·
ASCEND EAGLE INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
36
Basic Information
- Brand Name
- Beesure
- Primary DI
- 10817508021379
- Version / Model
- BE714SSP
- Company Name
- ASCEND EAGLE INCORPORATED
- Labeler DUNS
- 167102750
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2021-12-28
- Public Version
- 3
- Public Version Date
- 2022-05-24
- Public Version Status
- Update
- Public Device Record Key
- 0950812d-ed24-465c-86b8-8401e0d81620
Device Description
Beesure True Impression 3 in 1 trays Impression Tray 36 /BX , Green Posterior
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 |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60885 | Dental material cartridge-plunging applicator, two-component, manual | A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00817508021372 | GS1 | ||||
| Primary | 10817508021379 | GS1 | ||||
| Package | 20817508021376 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 7075536190
- [email protected]