ORTHOMETRIC ELASTOMERICS - INTRA ORAL
- Primary DI
- 07908470702000
- Brand
- ORTHOMETRIC ELASTOMERICS - INTRA ORAL
- Company
- ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
- Model
- 60.01.1005
- Device description
- ORTHODONTIC ELASTIC- LATEX- INTRA-ORAL- LIGHT 3/8
- Published
- 2022-09-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ECI | Band, Elastic, Orthodontic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ECI | Band, Elastic, Orthodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07908470702000 | Primary | GS1 | 0 | |
Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.
Alternate GTIN / UPC / EAN Codes
| Source identifier | Source length | GTIN-14 normalized | Indicator | EAN-13 | Conversion note |
|---|
| 07908470702000 | 14 | 07908470702000 | 0 | 7908470702000 | Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00. |
GMDN Terms
| Term | Definition |
|---|
| 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). |
Regulatory Flags
- DUNS number
- 898330003
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 07908611211880 | ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - GREEN | 60.05.5044 | | 2025-12-22 |
| 07908611211927 | ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - GREEN | 60.05.7044 | | 2025-12-22 |
| 07908611211934 | ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - TEAL GREEN | 60.05.7042 | | 2025-12-22 |
| 07908611211941 | ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - EMERALD GREEN | 60.05.7043 | | 2025-12-22 |
| 07908611211972 | ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - TEAL GREEN | 60.05.5142 | | 2025-12-22 |
| 07908611211989 | ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - LIME GREEN | 60.05.5145 | | 2025-12-22 |
| 07908611212054 | ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - ACQUA | 60.05.6141 | | 2025-12-22 |
| 07908611212061 | ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - EMERALD GREEN | 60.05.6143 | | 2025-12-22 |
| 07908611212085 | ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - NEON YELLOW | 60.05.6146 | | 2025-12-22 |
| 07908611212092 | ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - LIME GREEN | 60.05.6145 | | 2025-12-22 |
| 07908611212122 | ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - ACQUA | 60.05.7141 | | 2025-12-22 |
| 07908611212139 | ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - LIME GREEN | 60.05.7145 | | 2025-12-22 |
| 07908611212207 | ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - NEON YELLOW | 60.05.7146 | | 2025-12-22 |
| 07908611212740 | ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - LIME GREEN | 60.05.5045 | | 2025-12-22 |
| 07908611212757 | ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - EMERALD GREEN | 60.05.5043 | | 2025-12-22 |
| 07908611212795 | ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - TEAL GREEN | 60.05.6042 | | 2025-12-22 |
| 07908611212856 | ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - LIME GREEN | 60.05.6045 | | 2025-12-22 |
| 07908611212863 | ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - LIME GREEN | 60.05.7045 | | 2025-12-22 |
| 07908611212887 | ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - NEON YELLOW | 60.05.7046 | | 2025-12-22 |
| 07908611212894 | ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - ACQUA | 60.05.5141 | | 2025-12-22 |
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