FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertiflex™ VIP
DI: 00884662000611
·
Model: 140-9800
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vertiflex™ VIP
- Primary DI
- 00884662000611
- Version / Model
- 140-9800
- Catalog Number
- 140-9800
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-05
- Public Version
- 6
- Public Version Date
- 2025-05-20
- Public Version Status
- Update
- Public Device Record Key
- 5737ccae-5598-4727-94bb-667a42d755b8
Device Description
Instrument Platform Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQO | Prosthesis, Spinous Process Spacer/Plate | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47128 | Lumbar interspinous decompression instrument set, single-use | A collection of sterile surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, and an implant holder. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884662000611 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140004 | 000 |
| P140004 | 005 |
| P140004 | 016 |
| P140004 | 017 |
| P140004 | 024 |
| P140004 | 027 |
| P140004 | 028 |
| P140004 | 030 |
| P140004 | 032 |
| P140004 | 033 |