Biover TKM-2

GUDID 07640174510061

Disposable Microvascular Clamps, Arteries, double, Ø 1 to 2 mm

Biover AG

Vascular clamp, single-use

• Primary Device ID: 07640174510061
• NIH Device Record Key: ffc58f45-88bb-4b81-9a71-f2fb0a8f2f60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biover
• Version Model Number: TKM-2
• Catalog Number: TKM-2
• Company DUNS: 482102712
• Company Name: Biover AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch
• Phone: +41416300022
• Email: biover@biover.ch

Device Dimensions

• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Width: 3 Millimeter
• Length: 17 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640174510061 [Primary]
GS1	7640174510078 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011208

FDA Product Code

• DXC: Clamp, 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: 2016-09-27

On-Brand Devices [Biover]

• 7640174510276: Disposable Microvascular Clamps, Veins, double, Ø 2 mm
• 07640174510245: Disposable Microvascular Clamps, Veins, single, Ø 2 mm
• 07640174510221: Disposable Microvascular Clamps, Veins, double, Ø 1 to 2 mm
• 7640174510214: Disposable Microvascular Clamps, Veins, single, Ø 1 to 2 mm
• 07640174510184: Disposable Microvascular Clamps, Veins, double, Ø less than 1 mm
• 7640174510177: Disposable Microvascular Clamps, Veins, single, Ø less than 1 mm
• 07640174510146: Disposable Microvascular Clamps, Veins, double, Ø 0.2 to 1 mm
• 07640174510122: Disposable Microvascular Clamps, Veins, single, Ø 0.2 to 1 mm
• 07640174510108: Disposable Microvascular Clamps, Arteries, double, Ø 2 to 4 mm
• 07640174510085: Disposable Microvascular Clamps, Arteries, single, Ø 2 to 4 mm
• 07640174510061: Disposable Microvascular Clamps, Arteries, double, Ø 1 to 2 mm
• 7640174510054: Disposable Microvascular Clamps, Arteries, single, Ø 1 to 2 mm
• 7640174510030: Disposable Microvascular Clamps, Arteries, double, Ø less than 1 mm
• 07640174510009: Disposable Microvascular Clamps, Arteries, single, Ø less than 1 mm
• 07640174510405: Titanium needle holder for Supermicrosurgery, 150mm length, 0.2mm tip, curved, 8mm grip
• 07640174510399: Titanium micro forceps for Supermicrosurgery, platform, 150mm length, 0.1mm tip, 8mm grip
• 07640174510382: Titanium micro needle holder, 180 mm length, 0.4 mm tip, curved, 8mm grip
• 07640174510375: Titanium micro needle holder, 150mm length, 0.4mm tip, curved, 8mm grip
• 07640174510368: Titanium micro forceps for vascular surgery, platform, 180mm length, 0.2mm tip, 8mm grip
• 07640174510351: Titanium micro forceps for vascular surgery, platform, 150mm length, 0.2mm tip, 8mm grip