FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Phoenix Elastic Attachers
DI: 05060772890006
·
Model: AX-ELA-MIX
·
PHOENIX ORTHODONTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Phoenix Elastic Attachers
- Primary DI
- 05060772890006
- Version / Model
- AX-ELA-MIX
- Catalog Number
- AX-ELA-MIX
- Company Name
- PHOENIX ORTHODONTICS INC
- Labeler DUNS
- 002092976
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-08-17
- Public Version
- 2
- Public Version Date
- 2023-06-27
- Public Version Status
- Update
- Public Device Record Key
- 68541ad5-df40-44f9-b235-b6a87127334f
- Distribution End Date
- 2023-06-26
Device Description
ELASTIC ATTACHERS MIXED COLORS PK100
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62072 | Orthodontic elastomeric appliance pusher | A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05060772890051 | GS1 | ||||
| Primary | 05060772890006 | GS1 |
Customer Contacts
- Phone
- +1(816) 228-6594
- [email protected]