3ML LATEX-FREE LDS GASKET, BULK NON-STERILE 26201DG

GUDID 10020221062011

3ML LATEX-FREE LDS GASKET, BULK NON-STERILE; 20,000PC/CRTN

Exel International

General-purpose syringe, single-use

• Primary Device ID: 10020221062011
• NIH Device Record Key: 15ef3c5d-225f-4911-956b-d8dd74ef45a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3ML LATEX-FREE LDS GASKET, BULK NON-STERILE
• Version Model Number: 26201DG
• Catalog Number: 26201DG
• Company DUNS: 180572216
• Company Name: Exel International
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221062014 [Primary]
GS1	10020221062011 [Package]; Contains: 00020221062014; Package: Shipping carton [20000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861153

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

[10020221062011]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [3ML LATEX-FREE LDS GASKET, BULK NON-STERILE]

• 10020221062011: 3ML LATEX-FREE LDS GASKET, BULK NON-STERILE; 20,000PC/CRTN
• 00020221062014: 3ML LATEX-FREE LDS GASKET, BULK NON-STERILE; 20,000PC/CRTN