FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix Nickel Titanium
DI: 05060772897296
·
Model: N-RC4-016L
·
PHOENIX ORTHODONTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Phoenix Nickel Titanium
- Primary DI
- 05060772897296
- Version / Model
- N-RC4-016L
- Catalog Number
- N-RC4-016L
- Company Name
- PHOENIX ORTHODONTICS INC
- Labeler DUNS
- 002092976
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-08-17
- Public Version
- 2
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- 1c2615bd-e2ba-4587-851a-8d8576d5d947
Device Description
NT TYPE 4 REVERSE CURVE .016 LOWER 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 |
|---|---|---|---|---|
| 41397 | Orthodontic archwire | A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05060772897302 | GS1 | ||||
| Primary | 05060772897296 | GS1 |
Customer Contacts
- Phone
- +18162286594
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.016 | Inch |