FDA UDI
In Commercial Distribution
🇺🇸 United States
ARCUSdigma 3 USB
DI: B915011700410
·
Model: 01170041
·
zebris MEDICAL GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ARCUSdigma 3 USB
- Primary DI
- B915011700410
- Version / Model
- 01170041
- Catalog Number
- NA
- Company Name
- zebris MEDICAL GmbH
- Labeler DUNS
- 328971791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-20
- Public Version
- 1
- Public Version Date
- 2023-07-28
- Public Version Status
- New
- Public Device Record Key
- e9ed5f88-c566-4881-b5bb-19607d4b532e
Device Description
Opto-Electronic Face-Bow for monitoring and tracking of lower jaw movements, USB-Version
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | Dental | 872.2060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35700 | Facebow | A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B915011700410 | HIBCC |
Customer Contacts
- Phone
- +49735156270
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity