FDA.reportPublic FDA data

Guidewire Introducer Needle

Primary DI
20886333001600
Brand
Guidewire Introducer Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
GWI1902
Catalog number
GWI1902
Device description
Guidewire Introducer Needle 19ga x 7cm
Published
2016-09-20
Public version status
Update
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974745000MANAN GWI GUIDE WIRE INTRODUCERMedical Device Technologies, Inc.1998-04-06DRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333001600PackageGS125In Commercial Distribution
00886333001606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300160020886333001600
00886333001606008863330016068863330016060886333001606

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28
00858769006241Transseptal NeedlePPMDMDRC2018-11-28
00858769006258Transseptal NeedlePPMDMDRC2018-11-28
10884450151850Merit Advance®Merit Medical Systems, Inc.DRC2018-06-11
00858769006104SafeSept Transseptal GuidwirePPMDMDRC2018-03-02