Manan Medical Products, Inc.

Primary DI
00859013006178
Brand
Manan Medical Products, Inc.
Company
MANAN MEDICAL PRODUCTS, INC.
Model
GWI1802EWW
Catalog number
GWI1802EWW
Device description
"Guide Wire Introducer Needle With Window Wall Hub18GA.ETW X 2.75"""
Published
2016-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851834000MANAN GWI GUIDE WIRE INTRODUCERManan Manufacturing Co., Inc.1985-07-11DWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859013006175PackageGS110Not in Commercial Distribution
20859013006172PackageGS110Not in Commercial Distribution
00859013006178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085901300617510859013006175
2085901300617220859013006172
00859013006178008590130061788590130061780859013006178

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. A stylet/obturator may be included with the needle, however additional introduction devices are not included (i.e., not a set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.75Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
224-625-8331David.Gasparik@argonmedical.com

Regulatory Flags#

DUNS number
831737957
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859013006031Medistar/Hatch (Private Label)FNM-2205-UGFNM-2205-UG2016-10-14
00859013006109Manan Medical Products, Inc.5025025025022016-10-26
00859013006116Manan Medical Products, Inc.5025055025052016-10-26
00859013006123Manan Medical Products, Inc.5025065025062016-10-26
00859013006130Manan Medical Products, Inc.5025075025072016-10-26
00859013006147Manan Medical Products, Inc.5025145025142016-10-26
00859013006154Manan Medical Products, Inc.5026525026522016-10-26
00859013006161Manan Medical Products, Inc.GWI1802EUSGWI1802EUS2016-10-26
00859013006185Manan Medical Products, Inc.GWI20015EWWGWI20015EWW2016-10-26
00859013006079MPM Medical Supply (Private Label)LBN-2020LBN-20202017-01-05
00859013006017MPM Medical Supply (Private Label)KOP2003KOP20032017-01-05
00859013006024MPM Medical Supply (Private Label)KOP2005KOP20052017-01-12
00859013006048Midwest Medical Inc. (Private Label)CNM2206-MMCNM2206-MM2016-09-21
00859013006055MPM Medical Supply (Private Label)KOP2007KOP20072017-01-05
00859013006062MPM Medical Supply (Private Label)KOP2010KOP20102017-01-05
00859013006093MPM Medical Supply (Private Label)TNL0815TNL08152017-01-05
00859013006000MPM Medical Supply (Private Label)BMNJ-MEC-1110BMNJ-MEC-11102017-01-12
20859013006011MPM Medical Supply (Private Label)KOP2003KOP20032017-01-05
20859013006028MPM Medical Supply (Private Label)KOP2005KOP20052017-01-12
20859013006035Medistar/Hatch (Private Label)FNM-2205-UGFNM-2205-UG2016-10-14

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