CURE LP

GUDID B167900455000

MEDITECH SPINE, LLC

Intraoperative bone pin/screw, sterile
Primary Device IDB167900455000
NIH Device Record Keye01a092d-12db-473f-b960-2e57ba829802
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE LP
Version Model Number900-455-00
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB167900455000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


[B167900455000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-11

On-Brand Devices [CURE LP]

B167T940141370T-9-40141-37
B167T940141360T-9-40141-36
B167T940141350T-9-40141-35
B167T940141340T-9-40141-34
B167T940141330T-9-40141-33
B167T940141320T-9-40141-32
B167T940141310T-9-40141-31
B167T940141300T-9-40141-30
B167T940141290T-9-40141-29
B167T940051450T-9-40051-45
B167T940051440T-9-40051-44
B167T940051430T-9-40051-43
B167T940051420T-9-40051-42
B167T940051410T-9-40051-41
B167T940051400T-9-40051-40
B167T940051390T-9-40051-39
B167T940051380T-9-40051-38
B167T940051370T-9-40051-37
B167T940051360T-9-40051-36
B167T940051350T-9-40051-35
B167T940051340T-9-40051-34
B167T940051330T-9-40051-33
B167T940041450T-9-40041-45
B167T940041440T-9-40041-44
B167T940041430T-9-40041-43
B167T940041420T-9-40041-42
B167T940041410T-9-40041-41
B167S4942460602S1-9-42460-60
B167S4942460552S1-9-42460-55
B167S2942460501S1-9-42460-50
B167S4942460452S1-9-42460-45
B167S4942460402S1-9-42460-40
B167S2942460351S1-9-42460-35
B167S4942460302S1-9-42460-30
B167S2942460251S1-9-42460-25
B167S4942460202S1-9-42460-20
B167S2942455601S1-9-42455-60
B167S4942455552S1-9-42455-55
B167S2942455501S1-9-42455-50
B167S2942455451S1-9-42455-45
B167S2942455401S1-9-42455-40
B167S2942455351S1-9-42455-35
B167S2942455301S1-9-42455-30
B167S4942455252S1-9-42455-25
B167S2942455201S1-9-42455-20
B167S2942360601S1-9-42360-60
B167S4942360552S1-9-42360-55
B167S2942360501S1-9-42360-50
B167S2942360451S1-9-42360-45
B167S2942360401S1-9-42360-40

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