SUMMIT MEDICAL 2010

GUDID 00810061911975

COMFORT TIP, STERILE, LARGE

KRISHNA IMPORTS INC

Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug

• Primary Device ID: 00810061911975
• NIH Device Record Key: ee975baf-dea4-4a5a-920d-866995df10fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUMMIT MEDICAL
• Version Model Number: 2010
• Catalog Number: 2010
• Company DUNS: 081853285
• Company Name: KRISHNA IMPORTS INC
• Device Count: 2
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com
• Phone: 8592594925
• Email: info@stephensinst.com

Device Dimensions

• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter
• Outer Diameter: 0.99 Millimeter

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
• 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	00810061911227 [Primary]
GS1	00810061911975 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140352

FDA Product Code

• LZU: Plug, Punctum

Sterilization

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

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

[00810061911975]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-22
• Device Publish Date: 2024-01-12

On-Brand Devices [SUMMIT MEDICAL]

• 00810061911937: ACCUFLO, STERILE, X-LARGE
• 00810061911920: ACCUFLO, STERILE, LARGE
• 00810061911913: ACCUFLO, STERILE, MEDIUM
• 00810061911982: ACCUFLO, STERILE, SMALL
• 00810061911975: COMFORT TIP, STERILE, LARGE
• 00810061911968: COMFORT TIP, STERILE, MEDIUM
• 00810061911951: COMFORT TIP, STERILE, SMALL
• 00810061911944: COMFORT TIP, STERILE, X-SMALL