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 Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle

• 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.

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• 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