FDA.reportPublic FDA data

MPM Medical Supply (Private Label)

Primary DI
00859013006024
Brand
MPM Medical Supply (Private Label)
Company
MANAN MEDICAL PRODUCTS, INC.
Model
KOP2005
Catalog number
KOP2005
Device description
20 GA X 5 CM Breast Localization Needle With Two Wires
Published
2017-01-12
Public version status
Update
Distribution status
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
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
10859013006021PackageGS110In Commercial Distribution
20859013006028PackageGS110In Commercial Distribution
00859013006024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085901300602110859013006021
2085901300602820859013006028
00859013006024008590130060248590130060240859013006024

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
Length5Centimeter

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08