MPM Medical Supply (Private Label) KOP2010

GUDID 20859013006066

20GA X 10CM (Breast Localization Needle With Two Wires)

MANAN MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 20859013006066
• NIH Device Record Key: 135c0161-6468-4982-adf4-bdf1614b8a93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPM Medical Supply (Private Label)
• Version Model Number: KOP2010
• Catalog Number: KOP2010
• Company DUNS: 831737957
• Company Name: MANAN MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com

Device Dimensions

• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859013006062 [Primary]
GS1	10859013006069 [Package]; Contains: 00859013006062; Package: Tyvek Pouch [10 Units]; In Commercial Distribution
GS1	20859013006066 [Package]; Contains: 10859013006069; Package: Unit Boxes [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863848

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20859013006066]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-05

On-Brand Devices [MPM Medical Supply (Private Label)]

• 20859013006097: 8GA X 15 CM (Target Needle-Locking)
• 20859013006073: 20 GA X 2" Huber Needle Used Only for Push and Pull of Saline Through Access Port of Lap Band
• 20859013006066: 20GA X 10CM (Breast Localization Needle With Two Wires)
• 20859013006059: 20GA X 7CM (Breast Localization Needle With Two Wires)
• 20859013006028: 20 GA X 5 CM Breast Localization Needle With Two Wires
• 20859013006011: 20GA X 3 CM (Breast Localization Needle With Two Wires)
• 00859013006000: 11 GA X 4" Double Diamond J-Type Bone Needle With 14 GA Extraction Cannula