FDA UDI
In Commercial Distribution
🇺🇸 United States
Endodontic Hand Instrument
DI: D716TNSRBGC625R501
·
Model: TNSRBGC625R50
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Endodontic Hand Instrument
- Primary DI
- D716TNSRBGC625R501
- Version / Model
- TNSRBGC625R50
- Catalog Number
- TNSRBGC625R50
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 1
- Public Version Date
- 2024-04-02
- Public Version Status
- New
- Public Device Record Key
- 2cfe64c3-b61e-486f-b161-38188a0bc2ba
Device Description
GuttaCore for Reciproc Blue - Size Verifier R50
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIL | GAUGE, DEPTH, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31878 | Manual endodontic file/rasp, reusable | A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D716TNSRBGC625R500 | HIBCC | ||||
| Primary | D716TNSRBGC625R501 | HIBCC |