FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDO 1500 MID MEDI
DI: J015504000110
·
Model: MID
·
MICRO MEGA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ENDO 1500 MID MEDI
- Primary DI
- J015504000110
- Version / Model
- MID
- Catalog Number
- 50400011
- Company Name
- MICRO MEGA
- Labeler DUNS
- 276075371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2019-06-13
- Public Version Status
- Update
- Public Device Record Key
- bd06e880-cf45-448b-acbb-7de9047024c6
Device Description
Dental handpiece for endontic treatment which works with Sonic vibtration
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
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43698 | Dental power tool system, pneumatic | An assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating instruments (e.g., drill bits, burs, polishing disks). This system is pneumatically-powered (gas-powered), normally by compressed air via a connecting hose to the handpiece/motor. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J015504000110 | HIBCC | ||||
| Direct Marking | J015504000111 | HIBCC |