Superion Indirect Decompression System 101-9812

GUDID 00884662000543

Superion Indirect Decompression System, 12mm

VERTIFLEX, INC.

Lumbar interspinous decompression spacer, sterile
Primary Device ID00884662000543
NIH Device Record Keyb727ef07-13b9-421a-b06f-2473f215abe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperion Indirect Decompression System
Version Model Number12mm
Catalog Number101-9812
Company DUNS005235436
Company NameVERTIFLEX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter
Width12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100884662000543 [Primary]

FDA Product Code

NQOProsthesis, Spinous Process Spacer/Plate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-07
Device Publish Date2019-02-04

On-Brand Devices [Superion Indirect Decompression System]

00884662000567Superion Indirect Decompression System, 16mm
00884662000550Superion Indirect Decompression System, 14mm
00884662000543Superion Indirect Decompression System, 12mm
00884662000536Superion Indirect Decompression System, 10mm
00088466000529Superion Indirect Decompression System, 8mm
00884662000529Superion Indirect Decompression System, 8mm

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