CRW™

GUDID M248CRWBP1

CRW™ BiopsyPlus Kit - Single Use

INTEGRA LIFESCIENCES CORPORATION

Brain biopsy procedure kit
Primary Device IDM248CRWBP1
NIH Device Record Keycdb77ab8-fb1d-4082-b9fa-7ae2f5d3f7d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRW™
Version Model NumberCRWBP
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780252603 [Primary]
HIBCCM248CRWBP1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-16
Device Publish Date2016-07-26

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