FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental City
DI: D771391781
·
Model: 39-1781
·
ICP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Dental City
- Primary DI
- D771391781
- Version / Model
- 39-1781
- Company Name
- ICP, INC.
- Labeler DUNS
- 808371371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-07-15
- Public Version
- 1
- Public Version Date
- 2021-07-23
- Public Version Status
- New
- Public Device Record Key
- 8ee50981-9bff-4c91-9f35-91a0b29bac70
Device Description
Barbed Broaches XX-Fine 10/Pack Yellow
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 |
|---|---|---|---|---|
| EKW | Broach, Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63202 | Endodontic broach, serrated, single-use | A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. 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 | D7713917810 | HIBCC | ||||
| Primary | D771391781 | HIBCC |