SCHWERT
- Primary DI
- E89656540
- Brand
- SCHWERT
- Company
- A. Schweickhardt GmbH & Co. KG
- Model
- 5654
- Catalog number
- 5654
- Device description
- Molar band seater 026-355
- Published
- 2023-03-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ECR | SETTER, BAND, ORTHODONTIC |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ECR | Setter, Band, Orthodontic | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| E89656540 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthodontic appliance dimension gauge | A dental instrument intended to be used for accurate measurement of the dimensions of an orthodontic appliance (e.g., orthodontic bracket height) especially as it relates to patient oral anatomy during the fitting of the appliance (e.g., determining distance from the incisal edge to an orthodontic bracket locator blade). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +49746498910700 | contact@schwert.com |
Regulatory Flags
- DUNS number
- 341195628
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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