Breast Needle Locator BNL-2005

GUDID 20813079020374

20ga (0.9mm) x 5cm

REMINGTON MEDICAL, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID20813079020374
NIH Device Record Key337350dd-f375-40a3-8dd0-f0ce27cb599c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreast Needle Locator
Version Model NumberBNL-2005
Catalog NumberBNL-2005
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 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)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com
Phone+1(800)989-0057
EmailQuality@Remmed.com

Device Dimensions

Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge
Needle Gauge20 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079020370 [Primary]
GS110813079020377 [Package]
Contains: 00813079020370
Package: Inner Carton [10 Units]
In Commercial Distribution
GS120813079020374 [Package]
Contains: 10813079020377
Package: Shipping Carton [10 Units]
In Commercial Distribution

FDA Product Code

MIJNEEDLE, TUMOR LOCALIZATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

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Ethylene Oxide

[20813079020374]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

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Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

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Ethylene Oxide

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Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

[20813079020374]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

On-Brand Devices [Breast Needle Locator]

1081307902039120ga (0.9mm) x 10cm
1081307902038420ga (0.9mm) x 7cm
2081307902037420ga (0.9mm) x 5cm
1081307902036020ga (0.9mm) x 3cm
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