Endoso

GUDID 06975202770362

Hunan Endoso Life Technology Co., Ltd

Rigid optical laparoscope

• Primary Device ID: 06975202770362
• NIH Device Record Key: 8fd8ca27-4cf3-46ad-ba81-c9a405a0f96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoso
• Version Model Number: 4KA45
• Company DUNS: 722930494
• Company Name: Hunan Endoso Life Technology Co., Ltd
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975202770362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231725

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[06975202770362]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-22
• Device Publish Date: 2024-07-12

On-Brand Devices [Endoso]

• 06975202770379: 4KA45R
• 06975202770362: 4KA45
• 06975202770355: 4KA30R
• 06975202770348: 4KA30
• 06975202770331: 4KA0R
• 06975202770324: 4KA0
• 06975202770195: BC28-3
• 06975202770188: BC28-2
• 06975202770171: BC28-1
• 06975202770164: BC22-3
• 06975202770157: BC22-2
• 06975202770140: BC22-1
• 06975202770133: BC20-2
• 06975202770126: BC20-1
• 06975202770119: BC12-2
• 06975202770102: BC12-1
• 06975202773066: PUR12-2
• 06975202773073: PUR12-3
• 06975202773059: PUR12-1
• 06975202772946: PUR12-S2
• 06975202772939: PUR12-S1
• 06975202772922: PUR12-6
• 06975202772915: PUR12-5
• 06975202772908: PUR12-4
• 06975202772878: PUR12-S
• 06975202770522: P2-E
• 06975202770515: P2-D
• 06975202770508: P2-C
• 06975202770492: P2-B
• 06975202770485: P2-A
• 06975202770478: P1-E
• 06975202770317: P1-D
• 06975202770300: P1-C
• 06975202770294: P1-B
• 06975202770287: P1-A