Needle Guide Bracket Kit

GUDID 06944413811867

Edan Instruments, Inc.

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Primary Device ID06944413811867
NIH Device Record Key0bffc101-db28-453b-8980-20b5466a2c26
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle Guide Bracket Kit
Version Model NumberBGK-P5-1X
Company DUNS529173163
Company NameEdan Instruments, 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 Usefalse
Lot Batchfalse
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
GS106944413811867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2018-10-12

On-Brand Devices [Needle Guide Bracket Kit]

06944413811867BGK-P5-1X
06944413811850BGK-L50UB
06944413811843BGK-R20UB
06944413811836BGK-R15UB
06944413811829BGK-R10UB
06944413811812BGK-CR10UA
06944413811805BGK-L40UB
06944413811799BGK-R50UB
06944413811737BGK-001
06944413811720BGK-L40UB
06944413811713BGK-R15UB
06944413811706BGK-C5-2
06944413812703BGK-008
06944413811751BGK-003
06944413811744BGK-002
06944413811959BGK-007
06944413811782BGK-006
06944413811775BGK-005
06944413811768BGK-004
06944413813939BGK-009

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