FDA.reportPublic FDA data

Midwest Medical Inc. (Private Label)

Primary DI
20859013006042
Brand
Midwest Medical Inc. (Private Label)
Company
MANAN MEDICAL PRODUCTS, INC.
Model
CNM2206-MM
Catalog number
CNM2206-MM
Device description
22 GA x 15CM MARKED CHIBA NEEDLE
Published
2016-09-21
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
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851838000MANAN CHIBA PTC NEEDLEManan Manufacturing Co., Inc.1985-06-21KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859013006045PackageGS110In Commercial Distribution
20859013006042PackageGS110In Commercial Distribution
00859013006048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085901300604510859013006045
2085901300604220859013006042
00859013006048008590130060488590130060480859013006048

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

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
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
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
00859013006178Manan Medical Products, Inc.GWI1802EWWGWI1802EWW2016-10-26
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

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Primary DI, Brand, Company table
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