Primary Device ID | 10813079021930 |
NIH Device Record Key | f41c1a56-10d7-4603-afa9-9d991d29f992 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Guidewire Introducer Needle Guidewire Access Needle |
Version Model Number | GWI-1802-NS |
Catalog Number | GWI-1802-NS |
Company DUNS | 788472314 |
Company Name | REMINGTON MEDICAL, INC. |
Device Count | 125 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com | |
Phone | +1(800)989-0057 |
Quality@Remmed.com |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Needle Gauge | 18 Gauge |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813079021933 [Primary] |
GS1 | 10813079021930 [Package] Contains: 00813079021933 Package: Shipping Carton [8 Units] In Commercial Distribution |
GS1 | 80813079021939 [Unit of Use] |
DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-02 |
Device Publish Date | 2020-09-24 |
10813079022616 - VascuChek Surgical Probe | 2024-09-02 Surgical Probe (sterile) used with transceiver |
00813079022626 - VascuChek Transceiver | 2024-09-02 Hand-held, battery operated transceiver used to monitor blood flow. |
00813079022633 - VascuChek Charger | 2024-09-02 Replacement Charger used with the transceiver |
00813079022640 - VascuChek Kit | 2024-09-02 Kit that contains 1 transceiver, 1 clinical probe, 1 charger, and 1 pack of ultrasound gel |
10813079022654 - VascuChek Clinical Probe | 2024-09-02 Clinical Probe (non-sterile) used with transceiver. |
10813079020223 - Bone Marrow "I" Needle | 2020-10-02 15ga (1.8mm) x 1 7/8" (5cm) |
20813079020237 - Bone Marrow "I" Needle | 2020-10-02 16ga (1.7mm) x 1 7/8" (5cm) |
10813079020247 - Bone Marrow "J" Needle Double Diamond Tip | 2020-10-02 11ga (3.0mm) x 4in. (10cm) |