MP-2794-G14

GUDID 04573596210604

Puncture Guide Tube

FUJIFILM HEALTHCARE CORPORATION

Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable
Primary Device ID04573596210604
NIH Device Record Key9bd30539-46b2-4db3-9fa8-dcd16bec4509
Commercial Distribution StatusIn Commercial Distribution
Brand NameMP-2794-G14
Version Model NumberMP-2794-G14
Company DUNS718262719
Company NameFUJIFILM HEALTHCARE CORPORATION
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge
Needle Gauge14 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS104562122957359 [Previous]
GS104573596210604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


[04573596210604]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-26
Device Publish Date2021-07-17

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04573596212035 - L352024-01-30 Probe
04573596212455 - UST-2266-52024-01-30 Probe
04573596214176 - CL4416R12024-01-30 Probe
04573596214336 - C4212024-01-30 Probe
04573596214503 - CC41R22024-01-30 Probe
04573596214510 - C253A2024-01-30 Probe

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