Disposable Tear-Away Vascular Introducer Set 7007

GUDID 10813079020179

1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire

REMINGTON MEDICAL, INC.

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Primary Device ID10813079020179
NIH Device Record Keyb3728ad9-71ee-4b15-ab3f-c6f09546c164
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Tear-Away Vascular Introducer Set
Version Model Number7007
Catalog Number7007
Company DUNS788472314
Company NameREMINGTON MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100813079020172 [Primary]
GS110813079020179 [Package]
Contains: 00813079020172
Package: Inner Carton [10 Units]
In Commercial Distribution
GS120813079020176 [Package]
Package: Shipping Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

[10813079020179]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-07
Device Publish Date2018-11-10

On-Brand Devices [Disposable Tear-Away Vascular Introducer Set]

208130790202131 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
108130790202091 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
208130790201901 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
108130790201861 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
108130790201791 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
108130790201621 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
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