nvp

GUDID 90814008025117

PLIF Encoded 10x30 15mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage
Primary Device ID90814008025117
NIH Device Record Key47ed4132-47c7-46ac-8d04-f742b08f6e8a
Commercial Distribution StatusIn Commercial Distribution
Brand Namenvp
Version Model NumberPLE-615-L
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
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

Customer Support Contacts

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS190814008025117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[90814008025117]

Moist Heat or Steam Sterilization

[90814008025117]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-24
Device Publish Date2017-05-15

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