Superion Interspinous Spacer 100-9808

GUDID 00884662000222

Superion Interspinous Spacer, 8mm

VERTIFLEX, INC.

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Primary Device ID	00884662000222
NIH Device Record Key	f241b8f6-8edd-418f-9017-e6f6c06ed6da
Commercial Distribution Status	In Commercial Distribution
Brand Name	Superion Interspinous Spacer
Version Model Number	8mm
Catalog Number	100-9808
Company DUNS	005235436
Company Name	VERTIFLEX, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter
Width	8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884662000222 [Primary]

FDA Product Code

NQO	Prosthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-02-10

On-Brand Devices [Superion Interspinous Spacer]

00884662000307	Superion Interspinous Spacer, 16mm
00884662000284	Superion Interspinous Spacer, 14mm
00884662000260	Superion Interspinous Spacer, 12mm
00884662000246	Superion Interspinous Spacer, 10mm
00884662000222	Superion Interspinous Spacer, 8mm