FDA UDI
In Commercial Distribution
🇺🇸 United States
JPS BONE FILE
DI: 00192896031463
·
Model: 345-217
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JPS BONE FILE
- Primary DI
- 00192896031463
- Version / Model
- 345-217
- Catalog Number
- 345-217
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-13
- Public Version
- 1
- Public Version Date
- 2018-10-15
- Public Version Status
- New
- Public Device Record Key
- 8ff95ec1-fe74-4f87-987d-f7c55e0874d8
Device Description
JPS BONE FILE SINGLE ENDED DOUBLE SIDED
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMI | FILE, BONE, SURGICAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11702 | Bone file | A hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrument with a handle at the proximal end. The distal end may be flat or profiled (e.g., flat on one side and convex on the other). This device is typically used in orthopaedics, plastic surgery and dentistry. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896031463 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8.75 | Inch |