Celt ACD Vascular Closure Device 7F_ESP

GUDID 05391530280150

Celt ACD Vascular Closure Device 7F_ESP

VASORUM LIMITED

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