FDA UDI
In Commercial Distribution
🇺🇸 United States
Revolution External Plating System
DI: 00854641008136
·
Model: 617015
·
Metalogix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Revolution External Plating System
- Primary DI
- 00854641008136
- Version / Model
- 617015
- Company Name
- Metalogix
- Labeler DUNS
- 080859336
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-07
- Public Version
- 3
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 398d90b0-cf6f-41e3-a06d-e7b8062a1307
Device Description
Self Drill Half-Pin 4x20x215mm
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
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48011 | External orthopaedic fixation system, single-use | An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854641008136 | GS1 |
Customer Contacts
- Phone
- 833-653-2019
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181630 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Thread Length: 20mm | ||
| Device Size Text, specify | Diameter: 4mm |