FDA UDI
In Commercial Distribution
🇺🇸 United States
AURADONICS
DI: 00810033837012
·
Model: 812-004 OSE
·
AURADONICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AURADONICS
- Primary DI
- 00810033837012
- Version / Model
- 812-004 OSE
- Company Name
- AURADONICS INC.
- Labeler DUNS
- 608537379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-02
- Public Version
- 1
- Public Version Date
- 2020-01-10
- Public Version Status
- New
- Public Device Record Key
- c5f32511-dfb0-4563-bac6-cb78ffeeb4b4
Device Description
LATEX ELASTICS 3/16" 4.5 oz. - AMBER, 100 bags of 100, 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
- Yes
- 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 |
|---|---|---|---|---|
| 62074 | Orthodontic inter-arch elastic band | A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. 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 | 00810033837012 | GS1 |
Customer Contacts
- Phone
- 8567648866
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Away from sunlight or strong light
- Type
- Storage Environment Temperature
- Temperature Range
- 6 – 25 Degrees Celsius