Guidewire Introducer Needle Square Hub Access Needle GWI-1802WW-NS

GUDID 10813079021947

18ga (1.3mm) x 7cm

REMINGTON MEDICAL, INC.

Intra-arterial needle
Primary Device ID10813079021947
NIH Device Record Key21f85371-34f5-4b5f-a883-b8183870f429
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuidewire Introducer Needle Square Hub Access Needle
Version Model NumberGWI-1802WW-NS
Catalog NumberGWI-1802WW-NS
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count125
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 Datefalse
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

Device Dimensions

Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge
Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079021940 [Primary]
GS110813079021947 [Package]
Contains: 00813079021940
Package: Shipping Carton [8 Units]
In Commercial Distribution
GS180813079021946 [Unit of Use]

FDA Product Code

DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by REMINGTON MEDICAL, INC.

10813079022616 - VascuChek Surgical Probe2024-09-02 Surgical Probe (sterile) used with transceiver
00813079022626 - VascuChek Transceiver2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow.
00813079022633 - VascuChek Charger2024-09-02 Replacement Charger used with the transceiver
00813079022640 - VascuChek Kit2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel
10813079022654 - VascuChek Clinical Probe2024-09-02 Clinical Probe (non-sterile) used with transceiver.
10813079020223 - Bone Marrow "I" Needle2020-10-02 15ga (1.8mm) x 1 7/8" (5cm)
20813079020237 - Bone Marrow "I" Needle2020-10-02 16ga (1.7mm) x 1 7/8" (5cm)
10813079020247 - Bone Marrow "J" Needle Double Diamond Tip2020-10-02 11ga (3.0mm) x 4in. (10cm)

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