FDA UDI
In Commercial Distribution
🇺🇸 United States
AURADONICS
DI: 00810033833618
·
Model: 700-501 15
·
AURADONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AURADONICS
- Primary DI
- 00810033833618
- Version / Model
- 700-501 15
- 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
- 1
- Public Version Date
- 2020-01-07
- Public Version Status
- New
- Public Device Record Key
- 3db233fb-252c-4bba-89b7-a6b93c23db3f
Device Description
CHAIN CONT - CLEAR, 15 FT each, 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 |
|---|---|---|---|---|
| 62073 | Orthodontic inter-bracket elastic chain | A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). 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 | 00810033833618 | 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