CURE LP

GUDID B167S2942460351

MEDITECH SPINE, LLC

Spinal bone screw, non-bioabsorbable
Primary Device IDB167S2942460351
NIH Device Record Key3f4e6202-6c8a-43e1-9311-ea1558eecc13
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE LP
Version Model NumberS1-9-42460-35
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
HIBCCB167S1942460350 [Primary]
HIBCCB167S2942460351 [Package]
Package: [2 Units]
In Commercial Distribution
HIBCCB167S4942460352 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2017-10-06

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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