Klein Surgical GI1095U

GUDID 10850048763637

Universal Klein Vascular 25mm

Klein Surgical Systems, Inc.

Robotic surgical ligation clip applier

• Primary Device ID: 10850048763637
• NIH Device Record Key: 5467b23b-6853-4317-9b18-3385af7763d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klein Surgical
• Version Model Number: GI1095U
• Catalog Number: GI1095U
• Company DUNS: 072364974
• Company Name: Klein Surgical Systems, Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com
• Phone: 210-280-4324
• Email: info@kleinsurgical.com

Device Dimensions

• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter
• Length: 70 Millimeter
• Width: 8.6 Millimeter
• Height: 10.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850048763637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930496

FDA Product Code

• GCI: Laryngoscope, Endoscope

Sterilization

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

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

[10850048763637]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17

On-Brand Devices [Klein Surgical]

• 10850048763651: Klein Universal Robotic Bulldog
• 10850048763637: Universal Klein Vascular 25mm
• 10850048763620: Universal Klein Vascular 30mm
• 10850048763613: Ewing/Klein Chol Clamp
• 10850048763354: Klein Bulldog Applier 10mm Det
• 10850048763309: Klein Bulldog Applier 10mm
• 10850048763286: Endoscopic Bulldog Clamp 60mm
• 10850048763279: Klein Bulldog Clamp 60mm Curved
• 10850048763262: Klein Bulldog Clamp 45mm Curved
• 10850048763255: Klein Bulldog Clamp 25mm Curved
• 10850048763248: Klein Bulldog Clamp 17mm Curved
• 10850048763231: Klein Bulldog Clamp 35mm Straight
• 10850048763224: Klein Bulldog Clamp 25mm Straight
• 10850048763217: Klein Bulldog Clamp 17mm Straight
• 10850048763200: Klein Bulldog Clamp 60mm Straight
• 10850048763194: Klein Bulldog Clamp 45mm Straight
• 30850048763808: Disposable Monopolar Endoscopic Cord 10 ft. (3.0m)
• 10850048763644: Klein Sterilization Tray