FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental City
DI: D77139501
·
Model: 39-501
·
ICP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Dental City
- Primary DI
- D77139501
- Version / Model
- 39-501
- Company Name
- ICP, INC.
- Labeler DUNS
- 808371371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2021-07-19
- Public Version
- 1
- Public Version Date
- 2021-07-27
- Public Version Status
- New
- Public Device Record Key
- 05402746-b1cf-426e-bc96-601953a2d972
Device Description
Hedstrom Files 31mm #60
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
- No
- 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 |
|---|---|---|---|---|
| EKQ | Preparer, Root Canal Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63721 | Endodontic enlarger, single-use | A non-sterile 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D771395010 | HIBCC | ||||
| Primary | D77139501 | HIBCC |