Celt ACD Vascular Closure Device 7F_ESP

GUDID 05391530280150

Celt ACD Vascular Closure Device 7F_ESP

VASORUM LIMITED

Vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip Implantable vascular closure clip

• Primary Device ID: 05391530280150
• NIH Device Record Key: f7653a95-0022-4857-8a6f-599163bdf722
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celt ACD Vascular Closure Device 7F_ESP
• Version Model Number: KCLT-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: true
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530280150 [Primary]
GS1	05391530280167 [Package]; Package: Inner Carton [5 Units]; In Commercial Distribution
GS1	05391530280174 [Package]; Contains: 05391530280167; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-21

Devices Manufactured by VASORUM LIMITED

• 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
• 05391530280150 - Celt ACD Vascular Closure Device 7F_ESP: 2018-07-06Celt ACD Vascular Closure Device 7F_ESP
• 05391530280150 - Celt ACD Vascular Closure Device 7F_ESP: 2018-07-06 Celt ACD Vascular Closure Device 7F_ESP