FDA UDI In Commercial Distribution 🇺🇸 United States

Vertiflex Instrument Platform

DI: 00884662000611 · Model: 140-9800 · BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vertiflex Instrument Platform
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
4
Public Version Date
2020-10-21
Public Version Status
Update
Public Device Record Key
5737ccae-5598-4727-94bb-667a42d755b8

Device Description

Vertiflex Instrument Platform includes a Dilator Assembly (140-9501), Cannula Assembly (140-9502), & Reamer (140-9503)

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
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
NQO Prosthesis, Spinous Process Spacer/Plate

GMDN Terms

Code Name
47128 Lumbar interspinous decompression instrument set, single-use

Identifiers

Type ID
Primary 00884662000611