CURE OPEL-L

GUDID B16790044229T0

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit
Primary Device IDB16790044229T0
NIH Device Record Key05cebc72-6da7-4908-ab72-f2ea74bfd896
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE OPEL-L
Version Model Number900-442-29-T
Company DUNS182698477
Company NameMEDITECH SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCB16790044229T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


[B16790044229T0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-14
Device Publish Date2022-10-06

On-Brand Devices [CURE OPEL-L]

B16790044245T0900-442-45-T
B16790044244T0900-442-44-T
B16790044243T0900-442-43-T
B16790044242T0900-442-42-T
B16790044241T0900-442-41-T
B16790044240T0900-442-40-T
B16790044239T0900-442-39-T
B16790044238T0900-442-38-T
B16790044237T0900-442-37-T
B16790044236T0900-442-36-T
B16790044235T0900-442-35-T
B16790044234T0900-442-34-T
B16790044233T0900-442-33-T
B16790044232T0900-442-32-T
B16790044231T0900-442-31-T
B16790044230T0900-442-30-T
B16790044229T0900-442-29-T
B16790044228T0900-442-28-T
B16790044227T0900-442-27-T
B16790044226T0900-442-26-T
B16790044225T0900-442-25-T
B16790042900020900-429-00-02
B16790042900010900-429-00-01
B167900429000900-429-00
B16790042145T0900-421-45-T
B16790042144T0900-421-44-T
B16790042143T0900-421-43-T
B16790042142T0900-421-42-T
B16790042141T0900-421-41-T
B16790042140T0900-421-40-T
B16790042139T0900-421-39-T
B16790042138T0900-421-38-T
B16790042137T0900-421-37-T
B16790042136T0900-421-36-T
B16790042135T0900-421-35-T
B16790042134T0900-421-34-T
B16790042133T0900-421-33-T
B16790042132T0900-421-32-T
B16790042131T0900-421-31-T
B16790042130T0900-421-30-T
B16790042129T0900-421-29-T
B16790042128T0900-421-28-T
B16790042127T0900-421-27-T
B16790042126T0900-421-26-T
B16790042125T0900-421-25-T
B16790042100T0900-421-00-T
B1679004210001T0900-421-00-01-T

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