FDA UDI
In Commercial Distribution
🇺🇸 United States
AURADONICS
DI: 00810033831683
·
Model: 300-428 BK
·
AURADONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AURADONICS
- Primary DI
- 00810033831683
- Version / Model
- 300-428 BK
- Company Name
- AURADONICS INC.
- Labeler DUNS
- 608537379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-30
- Public Version
- 2
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- fddf3e90-b0d2-4f13-adf1-c4d178a34091
Device Description
CANES - BABY BLUE, 5K BULK LOOSE, 5000 devices per package, see www.auradonics.com
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
- No
- 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 |
|---|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41677 | Orthodontic archwire/bracket ligature | A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810033831683 | GS1 |
Customer Contacts
- Phone
- 8567648866
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 6 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from sunlight or strong light