MPM Medical Supply (Private Label)

Primary DI
20859013006066
Brand
MPM Medical Supply (Private Label)
Company
MANAN MEDICAL PRODUCTS, INC.
Model
KOP2010
Catalog number
KOP2010
Device description
20GA X 10CM (Breast Localization Needle With Two Wires)
Published
2017-01-05
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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863848000MANAN BREST TUMOR LOCALIZATION NEEDLEManan Manufacturing Co., Inc.1986-10-14GAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859013006069PackageGS110In Commercial Distribution
20859013006066PackageGS110In Commercial Distribution
00859013006062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085901300606910859013006069
2085901300606620859013006066
00859013006062008590130060628590130060620859013006062

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic stereotactic biopsy systemAn assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter

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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