FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RestoreUltra®SureScan®
DI: 00643169553125
·
Model: 97712
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RestoreUltra®SureScan®
- Primary DI
- 00643169553125
- Version / Model
- 97712
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 796986144
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-08
- Public Version
- 4
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- a04c6eb3-acc7-4004-b46d-516c82d1e3e7
- Distribution End Date
- 2023-03-31
Device Description
INS 97712 RSTRULTRA SS MRI EMAN COQUIPUL
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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Unknown | 3 | |
| QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64970 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable | An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169553125 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P840001 | 314 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 125 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 52 Degrees Celsius