FDA UDI
In Commercial Distribution
🇺🇸 United States
Midas Rex®
DI: 00613994601537
·
Model: PC710-R
·
MEDTRONIC POWERED SURGICAL SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midas Rex®
- Primary DI
- 00613994601537
- Version / Model
- PC710-R
- Company Name
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Labeler DUNS
- 098308849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-01
- Public Version
- 5
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- b44d3016-19b6-4e10-8945-9bfb5d780a90
Device Description
HOSE PC710-R MR7 PNEUMATIC REFURB
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
- No
- 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 |
|---|---|---|---|---|
| HBB | MOTOR, DRILL, PNEUMATIC | Neurology | 882.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37869 | Pneumatic surgical power tool hose | A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994601537 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090112 | 000 |