FDA UDI
Not in Commercial Distribution
🇺🇸 United States
POWERPRO
DI: 20845854028626
·
Model: PRO6135
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- POWERPRO
- Primary DI
- 20845854028626
- Version / Model
- PRO6135
- Catalog Number
- PRO6135
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 5e8126ba-ac3e-4229-8f82-36317b2aa7ae
- Distribution End Date
- 2023-12-03
Device Description
POWERPRO ELECTRIC II RECIPROCATOR HANDPIECE
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66243 | Bone/joint surgical power tool motorized handpiece/set, electric, reusable | An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes an electric motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 30845854028623 | GS1 | ||||
| Primary | 20845854028626 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius