FDA UDI
In Commercial Distribution
🇺🇸 United States
Safco K-Files
DI: D72310264453
·
Model: 1026445
·
SAFCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Safco K-Files
- Primary DI
- D72310264453
- Version / Model
- 1026445
- Catalog Number
- 1026445
- Company Name
- SAFCO DENTAL SUPPLY CO.
- Labeler DUNS
- 020417380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-11-21
- Public Version
- 1
- Public Version Date
- 2022-11-29
- Public Version Status
- New
- Public Device Record Key
- a7cd76bc-985b-45da-9b44-9b7ba4e07625
Device Description
Safco K-Files #30 31mm 6/box
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D72310264450 | HIBCC | ||||
| Primary | D72310264453 | HIBCC |