Medistar/Hatch (Private Label) FNM-2205-UG

GUDID 20859013006035

22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP)

MANAN MEDICAL PRODUCTS, INC.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 20859013006035
• NIH Device Record Key: 85e86619-ca76-4773-91bb-0539927f0161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medistar/Hatch (Private Label)
• Version Model Number: FNM-2205-UG
• Catalog Number: FNM-2205-UG
• 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

Device Dimensions

• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter
• Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859013006031 [Primary]
GS1	10859013006038 [Package]; Contains: 00859013006031; Package: Tyvek Pouch [10 Units]; In Commercial Distribution
GS1	20859013006035 [Package]; Contains: 10859013006038; Package: Unit Boxes [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851831

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

Ethylene Oxide

[20859013006035]

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: 2016-10-14

Devices Manufactured by MANAN MEDICAL PRODUCTS, INC.

• 00859013006000 - MPM Medical Supply (Private Label): 2018-07-06 11 GA X 4" Double Diamond J-Type Bone Needle With 14 GA Extraction Cannula
• 20859013006011 - MPM Medical Supply (Private Label): 2018-07-06 20GA X 3 CM (Breast Localization Needle With Two Wires)
• 20859013006028 - MPM Medical Supply (Private Label): 2018-07-06 20 GA X 5 CM Breast Localization Needle With Two Wires
• 20859013006035 - Medistar/Hatch (Private Label): 2018-07-0622GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP)
• 20859013006035 - Medistar/Hatch (Private Label): 2018-07-06 22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP)
• 20859013006042 - Midwest Medical Inc. (Private Label): 2018-07-06 22 GA x 15CM MARKED CHIBA NEEDLE
• 20859013006059 - MPM Medical Supply (Private Label): 2018-07-06 20GA X 7CM (Breast Localization Needle With Two Wires)
• 20859013006066 - MPM Medical Supply (Private Label): 2018-07-06 20GA X 10CM (Breast Localization Needle With Two Wires)
• 20859013006073 - MPM Medical Supply (Private Label): 2018-07-06 20 GA X 2" Huber Needle Used Only for Push and Pull of Saline Through Access Port of Lap Band