FDA.reportPublic FDA data

Guidewire Introducer Needle Winged Base Plate

Primary DI
20813079020275
Brand
Guidewire Introducer Needle Winged Base Plate
Company
REMINGTON MEDICAL, INC.
Model
BGWI-1802
Catalog number
BGWI-1802
Device description
18ga (1.3mm) x 7cm
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020278PackageGS110In Commercial Distribution
20813079020275PackageGS110In Commercial Distribution
00813079020271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902027810813079020278
2081307902027520813079020275
00813079020271008130790202718130790202710813079020271

GMDN Terms#

Term, Definition table
TermDefinition
Intra-arterial needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to puncture an artery. The needle may be heparinized to prevent blood clotting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813079021506Remington Medical, Inc Disposable Extension CablePK-155-BPK-155-B2026-04-10
00813079022664VascuChek TransceiverVC-TRX-02VC-TRX-022025-11-27
00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
00813079022008Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022015Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412BNAC-1412B2025-01-17
00813079022022Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416BNAC-1416B2025-01-17
00813079022039Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420BNAC-1420B2025-01-17
00813079022046Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610BNAC-1610B2025-01-17
00813079022053Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616BNAC-1616B2025-01-17
00813079022060Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1620BNAC-1620B2025-01-17
00813079022077Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1810BNAC-1810B2025-01-17
00813079022084Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416NAC-14162025-01-17
00813079022091Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1825NAC-18252025-01-17
00813079022107Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1410BNAC-1410B2025-01-17
00813079022114Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1412MNAC-1412M2025-01-17
00813079022121Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1416MNAC-1416M2025-01-17
00813079022138Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1420MNAC-1420M2025-01-17
00813079022145Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1610MNAC-1610M2025-01-17
00813079022152Remington Medical, Inc. Automatic Cutting Needle (NAC)NAC-1616MNAC-1616M2025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14
03661219510970LANDANGERLANDANGERDWS2026-07-12
03661219512660DELACROIX-CHEVALIERLANDANGERDWS2026-07-12
03661219528371LANDANGERLANDANGERDWS2026-07-12
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389989DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219390220DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510062DELACROIX-CHEVALIERLANDANGERDWS2026-07-08