SPOT Endosopic Marker GIs-44

GUDID 00893029002441

GI Supply, Inc.

Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink Tissue marking ink

• Primary Device ID: 00893029002441
• NIH Device Record Key: 44302e8f-39a2-4023-a425-a3244f44f97d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOT Endosopic Marker
• Version Model Number: GIS-44
• Catalog Number: GIs-44
• Company DUNS: 160990313
• Company Name: GI Supply, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com
• Phone: 1-800-451-5797
• Email: customer_service@gi-supply.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893029002069 [Primary]
GS1	00893029002441 [Package]; Contains: 00893029002069; Package: 10 Count Canister [10 Units]; In Commercial Distribution

FDA Product Code

• NBG: Marker,Colon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-17
• Device Publish Date: 2016-09-24

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• 10893029002608 - MoonPants ML: 2021-07-28 MoonPants ML single-use non-sterile garment
• 10893029002615 - MoonPants XL: 2021-07-28 MoonPants XL single-use non-sterile garment
• 10893029002622 - MoonPants Long: 2021-07-28 MoonPants Long single-use non-sterile garment
• 00893029002670 - SportShorts XS: 2021-07-28 SportShorts XS single-use non-sterile garment
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