EXEL HYPO NDL 16GX1" BULK, NON-STERILE 26421BN

GUDID 10020221664215

EXEL HYPO NDL 16GX1" BULK, NON-STERILE

Exel International

Hypodermic needle, single-use

• Primary Device ID: 10020221664215
• NIH Device Record Key: 584df49e-f1eb-4715-b3eb-702f3aea4721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL HYPO NDL 16GX1" BULK, NON-STERILE
• Version Model Number: 26421BN
• Catalog Number: 26421BN
• 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
• 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
• 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
• 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	00020221664218 [Primary]
GS1	10020221664215 [Package]; Contains: 00020221664218; Package: Shipping carton [20000 Units]; In Commercial Distribution
GS1	20020221664212 [Package]; Package: Shipping carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861153

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

[10020221664215]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [EXEL HYPO NDL 16GX1" BULK, NON-STERILE ]

• 10020221664215: EXEL HYPO NDL 16GX1" BULK, NON-STERILE
• 00020221664218: EXEL HYPO NDL 16GX1" BULK, NON-STERILE (2x10000 BAG) 20k/crtn