FIX GIH-4211

GUDID 07290109742656

GIH dental implant 4.2mm Dia length 11.5 mm

BHI IMPLANTS LTD

Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece

• Primary Device ID: 07290109742656
• NIH Device Record Key: 489f004e-13d4-4613-bc8c-f012f784de98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIX
• Version Model Number: 1
• Catalog Number: GIH-4211
• Company DUNS: 600330916
• Company Name: BHI IMPLANTS LTD
• 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: false
• 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: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com

Device Dimensions

• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11.5 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109742656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-29
• Device Publish Date: 2021-03-21

On-Brand Devices [FIX]

• 07290109742700: GIH dental implant 5.0 mm Dia length 13 mm
• 07290109742694: GIH dental implant 5.0 mm Dia length 11 mm
• 07290109742687: GIH dental implant 5.0 mm Dia length 10 mm
• 07290109742670: GIH dental implant 5.0 mm Dia length 8 mm
• 07290109742663: GIH dental implant 4.2mm Dia length 13 mm
• 07290109742656: GIH dental implant 4.2mm Dia length 11.5 mm
• 07290109742649: GIH dental implant 4.2mm Dia length 10 mm
• 07290109742632: GIH dental implant 4.2mm Dia length 8 mm
• 07290109742625: GIH dental implant 3.75 mm Dia length 13 mm
• 07290109742618: GIH dental implant 3.75 mm Dia length 11 mm
• 07290109742601: GIH dental implant 3.75 mm Dia length 10 mm
• 07290109742595: GIH implant 3.75 mm Dia length 8 mm
• 07290109742885: GIH dental implant 3.5 mm Dia length 13 mm
• 07290109742878: GIH dental implant 3.5 mm Dia length 11 mm
• 07290109742861: GIH dental implant 3.5 mm Dia length 10 mm
• 07290109742854: GIH implant 3.5 mm Dia length 8 mm
• 07290109747415: GIH dental implant 5.0 mm Dia length 16 mm
• 07290109747408: GIH dental implant 4.2mm Dia length 16 mm
• 07290109747392: GIH dental implant 3.75 mm Dia length 16 mm