FDA UDI
In Commercial Distribution
🇺🇸 United States
MACRO-LOCK STARTER DRILL 2
DI: ERTDA000924000200000
·
Model: 4520119
·
RECHERCHES TECHNIQUES DENTAIRES
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MACRO-LOCK STARTER DRILL 2
- Primary DI
- ERTDA000924000200000
- Version / Model
- 4520119
- Catalog Number
- 4520119
- Company Name
- RECHERCHES TECHNIQUES DENTAIRES
- Labeler DUNS
- 260303508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 4f991779-5661-4cb8-a292-864f28ed9fc4
Device Description
Dental drill
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
- Yes
- 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 |
|---|---|---|---|---|
| DZA | DRILL, DENTAL, INTRAORAL | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31876 | Endodontic enlarger, reusable | A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | ERTD4520119012 | HIBCC | 1 | In Commercial Distribution | ||
| Package | ERTD4520119V001 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | ERTDA000924000200000 | HIBCC |