FDA UDI
In Commercial Distribution
🇺🇸 United States
Apex
DI: D875S11685127105
·
Model: S11685-12-71
·
MASTERLINK LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Apex
- Primary DI
- D875S11685127105
- Version / Model
- S11685-12-71
- Company Name
- MASTERLINK LLC
- Labeler DUNS
- 017009932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3ac281f9-f1fc-4e3f-9521-d6a7c2b226fe
Device Description
Size #2 Adult Dental X-Ray Sensor for radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUH | System,X-Ray,Extraoral Source,Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44905 | Dental digital imaging sensor, intraoral | An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D875S11685127105 | HIBCC |
Customer Contacts
- Phone
- (800) 869-0915
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163282 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 41.9 | Millimeter | |
| Width | 30.4 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius