FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Phoenix Stainless Steel
DI: 05060779991027
·
Model: S-028L
·
PHOENIX ORTHODONTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Phoenix Stainless Steel
- Primary DI
- 05060779991027
- Version / Model
- S-028L
- Catalog Number
- S-028L
- Company Name
- PHOENIX ORTHODONTICS INC
- Labeler DUNS
- 002092976
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-08-17
- Public Version
- 5
- Public Version Date
- 2024-08-15
- Public Version Status
- Update
- Public Device Record Key
- dff6ef14-06a7-439f-8df8-c0091d2d799c
- Distribution End Date
- 2023-06-11
Device Description
.028 STRAIGHT 14 Inch STAINLESS PK10
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| DZC | WIRE, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38608 | Dental wrought alloy | A wrought alloy (metal) intended to be used in dentistry to make individually formed retentive elements, clasps for removable dentures, posts for orthodontic appliances, and other dental devices. It is marketed in a variety of forms, dimensions and materials. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05060779991034 | GS1 | ||||
| Primary | 05060779991027 | GS1 |
Customer Contacts
- Phone
- +18162286628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14 | Inch | |
| Outer Diameter | 0.028 | Inch |