FDA UDI
In Commercial Distribution
🇺🇸 United States
VECTOR® Screw
DI: J01825242
·
Model: 2524.2
·
Scheu-Dental GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- VECTOR® Screw
- Primary DI
- J01825242
- Version / Model
- 2524.2
- Company Name
- Scheu-Dental GmbH
- Labeler DUNS
- 317683787
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-11-18
- Public Version
- 1
- Public Version Date
- 2024-11-26
- Public Version Status
- New
- Public Device Record Key
- a6a57765-8d3b-4320-bf14-3f75e0fd0414
Device Description
VECTOR® 600, rapid palatal expansion screw, 10.40 x 4.00 x 13.00 mm Expansion 9.0 mm
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYJ | Retainer, Screw Expansion, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65677 | Orthodontic palate expander screw, bonded | An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | J01825240 | HIBCC | ||||
| Primary | J01825242 | HIBCC |