AccessGUDID - DEVICE: Vertiflex™ VIP (00884662000611)

GUDID

Device Identifier (DI) Information

Brand Name: Vertiflex™ VIP
Version or Model: 140-9800
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 140-9800
Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Primary DI Number: 00884662000611
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824951958 *Terms of Use

Device Description: Instrument Platform Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NQO	Prosthesis, Spinous Process Spacer/Plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140004	000
P140004	005
P140004	016
P140004	017
P140004	024
P140004	027
P140004	028
P140004	030
P140004	032
P140004	033

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5737ccae-5598-4727-94bb-667a42d755b8
Public Version Date: May 20, 2025
Public Version Number: 6
DI Record Publish Date: April 05, 2018