Closed Needle Guide LNGC-2022

GUDID 20813079020411

20/22ga (0.9/0.7mm)

REMINGTON MEDICAL, INC.

Nonimplantable needle guide, single-use
Primary Device ID20813079020411
NIH Device Record Key3044c33e-f4f1-4a90-8598-d0a8241c0ba7
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosed Needle Guide
Version Model NumberLNGC-2022
Catalog NumberLNGC-2022
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count2
DM Exempttrue
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 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
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 Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge
Needle Gauge22 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079020417 [Primary]
GS110813079020414 [Package]
Contains: 00813079020417
Package: Inner Carton [10 Units]
In Commercial Distribution
GS120813079020411 [Package]
Contains: 10813079020414
Package: Shipping Carton [10 Units]
In Commercial Distribution
GS180813079020413 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, x-ray, mammographic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

Ethylene Oxide

[20813079020411]

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 [Closed Needle Guide]

2081307902041120/22ga (0.9/0.7mm)
1081307902040714ga (2.1mm)
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.