FDA UDI
In Commercial Distribution
🇺🇸 United States
Separators
DI: 00190746060359
·
Model: 854-038056
·
AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Separators
- Primary DI
- 00190746060359
- Version / Model
- 854-038056
- Catalog Number
- 854-038056
- Company Name
- AMERICAN ORTHODONTICS CORPORATION
- Labeler DUNS
- 044668515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 3a2c055d-4635-4c4f-967d-3040cb208558
Device Description
ELASTOMERIC SEPARATORS LARGE BLUE RADIO-OPAQUE 1000/PK
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 |
|---|---|---|---|---|
| 63078 | Birdshot retinochoroidopathy (BSRC) IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic condition birdshot retinochoroidopathy (BSRC), also known as birdshot chorioretinopathy or birdshot uveitis, which is associated with the HLA-A29 allele, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190746060359 | GS1 |
Customer Contacts
- Phone
- +1(800)558-7687
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 38 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Light