FDA UDI
In Commercial Distribution
🇺🇸 United States
External Remote Controller
DI: 00812258022877
·
Model: ERC2P
·
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- External Remote Controller
- Primary DI
- 00812258022877
- Version / Model
- ERC2P
- Catalog Number
- EAD-P2-010
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 5
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- 9108056c-c0e9-4e68-9aee-9d5dba48737a
Device Description
External remote controller - for use with the PRECICE intramedullary limb lengthening system
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43538 | Distraction plate/rod adjustment remote control | A portable, hand-held, electrically-powered device intended to be used to noninvasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail) to achieve the correct length; it may be used intraoperatively to test the functionality of the plate/rod. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812258022877 | GS1 |
Customer Contacts
- Phone
- 855-435-5477
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | tool/instrument |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius