CURE IVIEW

GUDID B167900002350

MEDITECH SPINE, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDB167900002350
NIH Device Record Key10463b1d-b94c-47a1-98b1-26f3f695de1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCURE IVIEW
Version Model Number9-00002-35
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 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
HIBCCB167900002350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

[B167900002350]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-17
Device Publish Date2022-10-07

On-Brand Devices [CURE IVIEW]

B167S1900002450S1-9-00002-45
B167S1900002440S1-9-00002-44
B167S1900002430S1-9-00002-43
B167S1900002420S1-9-00002-42
B167S1900002410S1-9-00002-41
B167S1900002400S1-9-00002-40
B167S1900002390S1-9-00002-39
B167S1900002380S1-9-00002-38
B167S1900002370S1-9-00002-37
B167S1900002360S1-9-00002-36
B167S1900002350S1-9-00002-35
B167S1900002340S1-9-00002-34
B167S1900002330S1-9-00002-33
B167S1900002320S1-9-00002-32
B167S1900002310S1-9-00002-31
B167S1900002300S1-9-00002-30
B167S1900002290S1-9-00002-29
B167S1900002280S1-9-00002-28
B167S1900002270S1-9-00002-27
B167S1900002260S1-9-00002-26
B167S1900002250S1-9-00002-25
B1679000024509-00002-45
B1679000024409-00002-44
B1679000024309-00002-43
B1679000024209-00002-42
B1679000024109-00002-41
B1679000024009-00002-40
B1679000023909-00002-39
B1679000023809-00002-38
B1679000023709-00002-37
B1679000023609-00002-36
B1679000023509-00002-35
B1679000023409-00002-34
B1679000023309-00002-33
B1679000023209-00002-32
B1679000023109-00002-31
B1679000023009-00002-30
B1679000022909-00002-29
B1679000022809-00002-28
B1679000022709-00002-27
B1679000022609-00002-26
B1679000022509-00002-25
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