EXEL HYPO NDL 27GX1/2" BULK,N-S 26400BN

GUDID 10020221664000

EXEL HYPO NDL 27GX1/2" BULK,N-S, 20,000/CRTN

Exel International

Hypodermic needle, single-use

• Primary Device ID: 10020221664000
• NIH Device Record Key: b45d31ea-ebc7-4342-b9af-c41a2f0e5814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXEL HYPO NDL 27GX1/2" BULK,N-S
• Version Model Number: 26400BN
• Catalog Number: 26400BN
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020221664003 [Primary]
GS1	10020221664000 [Package]; Contains: 00020221664003; Package: Shipping carton [20000 Units]; In Commercial Distribution
GS1	20020221664007 [Package]; Package: Shipping carton [2 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

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

[10020221664000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-31
• Device Publish Date: 2023-03-23

On-Brand Devices [EXEL HYPO NDL 27GX1/2" BULK,N-S]

• 10020221664000: EXEL HYPO NDL 27GX1/2" BULK,N-S, 20,000/CRTN
• 00020221664003: EXEL HYPO NDL 27GX1/2" BULK,N-S, 20,000/CRTN (2X10k DOUBLE BAGS)