Clarke-Reich Macro

GUDID 00888937011432

Laparoscopic Knot Pusher; 5-0 and Larger; 45cm working length

Coopersurgical, Inc.

Needle holder, reusable

• Primary Device ID: 00888937011432
• NIH Device Record Key: fafa98ed-5f3e-440b-a23c-4e50009986d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarke-Reich Macro
• Version Model Number: M4601P
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937011432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903560

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Clarke-Reich Macro]

• 00888937011432: Laparoscopic Knot Pusher; 5-0 and Larger; 45cm working length
• 00888937011401: Laparoscopic Knot Pusher; 5-0 and Larger; 29cm working length