FDA UDI
In Commercial Distribution
🇺🇸 United States
ISRIE
DI: 06975043365987
·
Model: G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25
·
Hansfive (Hangzhou) Dental Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ISRIE
- Primary DI
- 06975043365987
- Version / Model
- G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25
- Company Name
- Hansfive (Hangzhou) Dental Technology Co.,Ltd.
- Labeler DUNS
- 413885255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 26e5ca23-e071-4edf-bd37-ee8dac06aa04
Device Description
Nickel Titanium Root Canal File 6 psc/pack Including G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25.
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63550 | Rotary/reciprocating endodontic file/rasp, single-use | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06975043365987 | GS1 |