FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Panoramic Corporation
DI: 00862309000316
·
Model: PC-1000/Laser 1000
·
YOUNG PS ACQUISITION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Panoramic Corporation
- Primary DI
- 00862309000316
- Version / Model
- PC-1000/Laser 1000
- Company Name
- YOUNG PS ACQUISITION, LLC
- Labeler DUNS
- 119620784
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-24
- Public Version
- 5
- Public Version Date
- 2022-09-27
- Public Version Status
- Update
- Public Device Record Key
- 355d6f84-89d5-4357-910c-7b88776c4915
- Distribution End Date
- 2017-05-24
Device Description
Unit, X-ray, Extraoral with timer-PC-1000/Laser 1000
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42066 | Stationary extraoral dental x-ray system, analogue | A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The image is from film or phosphor plate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862309000316 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K882436 | 000 |