FDA UDI
In Commercial Distribution
🇺🇸 United States
Endodontic Diagnostic Instrument
DI: 00859611006532
·
Model: EDX-S
·
JORDCO INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endodontic Diagnostic Instrument
- Primary DI
- 00859611006532
- Version / Model
- EDX-S
- Catalog Number
- EDX-S
- Company Name
- JORDCO INC
- Labeler DUNS
- 803063981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-08
- Public Version
- 1
- Public Version Date
- 2020-08-17
- Public Version Status
- New
- Public Device Record Key
- 816a429a-827b-4183-9e77-0dbbd94b5003
Device Description
e-Dx Kit Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64861 | Endodontic cold test foam wedge | A section of soft, spongy, compressible material intended to be used to perform a dental cold sensitivity test for detection of a dental fracture hidden beneath tooth enamel or a cusp, and/or to assess dental pulp health. It is designed to be submitted to very low temperatures, typically by being sprayed or injected with a coolant fluid, and then applied to a patient’s tooth surface to elicit a painful response. Tweezers-like tips intended to be mounted on a hand-held instrument while holding the foam wedges may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859611006532 | GS1 |
Customer Contacts
- Phone
- 503-531-3904
- [email protected]