FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GIRO-FILES
DI: J015201050071
·
Model: n015 L21
·
MICRO MEGA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
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Basic Information
- Brand Name
- GIRO-FILES
- Primary DI
- J015201050071
- Version / Model
- n015 L21
- Catalog Number
- 20105007
- Company Name
- MICRO MEGA
- Labeler DUNS
- 276075371
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-08-28
- Public Version
- 2
- Public Version Date
- 2026-02-12
- Public Version Status
- Update
- Public Device Record Key
- 52729aeb-94c7-4bce-a22d-a0e20fff30e7
- Distribution End Date
- 2021-04-30
Device Description
Endodontic instruments for professionnal 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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 40529 | Rotary/reciprocating endodontic file/rasp, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | J015201050079 | HIBCC | Box | 10 | Not in Commercial Distribution | 2021-04-30 |
| Primary | J015201050071 | HIBCC | ||||
| Unit of Use | J015201050070 | HIBCC |