Celt ACD PLUS Vascular Closure Device 7F

GUDID 05391530280679

Celt ACD PLUS Vascular Closure Device 7F (US)

VASORUM LIMITED

Implantable vascular closure clip

• Primary Device ID: 05391530280679
• NIH Device Record Key: eb04dce2-2126-45ce-bfab-7bf05aeb10fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celt ACD PLUS Vascular Closure Device 7F
• Version Model Number: CLT-07
• Company DUNS: 896197592
• Company Name: VASORUM LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530280679 [Primary]
GS1	05391530280686 [Package]; Package: Inner Carton [5 Units]; In Commercial Distribution
GS1	05391530280693 [Package]; Contains: 05391530280686; Package: Shipper Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150006

FDA Product Code

• MGB: Device, Hemostasis, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-02
• Device Publish Date: 2025-04-24

Devices Manufactured by VASORUM LIMITED

• 05391530280624 - Celt ACD PLUS Vascular Closure Device 5F: 2025-05-02 Celt ACD PLUS Vascular Closure Device 5F (US).
• 05391530280655 - Celt ACD PLUS Vascular Closure Device 6F: 2025-05-02 Celt ACD PLUS Vascular Closure Device 6F (US)
• 05391530280679 - Celt ACD PLUS Vascular Closure Device 7F: 2025-05-02Celt ACD PLUS Vascular Closure Device 7F (US)
• 05391530280679 - Celt ACD PLUS Vascular Closure Device 7F: 2025-05-02 Celt ACD PLUS Vascular Closure Device 7F (US)
• 05391530280006 - Celt ACD Vascular Closure Device 5F: 2018-07-06 Celt ACD Vascular Closure Device 5F
• 05391530280037 - Celt ACD Vascular Closure Device 5F_ESP: 2018-07-06 Celt ACD Vascular Closure Device 5F_ESP
• 05391530280068 - Celt ACD Vascular Closure Device 6F: 2018-07-06 Celt ACD Vascular Closure Device 6F
• 05391530280099 - Celt ACD Vascular Closure Device 6F_ESP: 2018-07-06 Celt ACD Vascular Closure Device 6F_ESP
• 05391530280129 - Celt ACD Vascular Closure Device 7F: 2018-07-06 Celt ACD Vascular Closure Device 7F