FDA UDI
In Commercial Distribution
🇺🇸 United States
H-Files
DI: J015600298151
·
Model: N060 L31
·
MICRO MEGA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- H-Files
- Primary DI
- J015600298151
- Version / Model
- N060 L31
- Catalog Number
- 60029815
- Company Name
- MICRO MEGA
- Labeler DUNS
- 276075371
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-12-22
- Public Version
- 1
- Public Version Date
- 2020-12-30
- Public Version Status
- New
- Public Device Record Key
- adfd9d45-df16-47d5-afd6-6a60c7bb6a51
Device Description
Endodontic instrument for professional dental use only
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | J015600298159 | HIBCC | 10 | In Commercial Distribution | ||
| Primary | J015600298151 | HIBCC | ||||
| Unit of Use | J015600298150 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight