FDA UDI
In Commercial Distribution
🇺🇸 United States
PNP Tibia
DI: 00840194472500
·
Model: 01-1510-0007-S
·
ORTHOPEDIATRICS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- PNP Tibia
- Primary DI
- 00840194472500
- Version / Model
- 01-1510-0007-S
- Catalog Number
- 01-1510-0007-S
- Company Name
- ORTHOPEDIATRICS CORP.
- Labeler DUNS
- 796416191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-28
- Public Version
- 1
- Public Version Date
- 2025-06-05
- Public Version Status
- New
- Public Device Record Key
- e92b18b2-d068-4b50-bdbe-795e21e1933a
Device Description
Conical Reamer, 9.75mm, Short
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIJ | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45115 | Medullary canal orthopaedic reamer, rigid | An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840194472500 | GS1 |
Customer Contacts
- Phone
- +1(574)268-6379
- [email protected]