CURE LP

GUDID B167900460010

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit
Primary Device IDB167900460010
NIH Device Record Key1542998b-088a-4841-8ffc-5c2d55a0b917
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE LP
Version Model Number900-460-01
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 Numbertrue
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
HIBCCB167900460010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B167900460010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

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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