Straumann Emdogain 075.128W

GUDID 07630031730039

Straumann Emdogain, 5 x 0.3 ml (30 mg/ml)

Institut Straumann AG

Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material

• Primary Device ID: 07630031730039
• NIH Device Record Key: 74806913-b05c-471d-9642-084014f4e3d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann Emdogain
• Version Model Number: Emdogain
• Catalog Number: 075.128W
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com
• Phone: 1 800 4488168
• Email: info.usa@straumann.com

Device Dimensions

• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031730039 [Primary]
GS1	07630031747020 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P930021

FDA Product Code

• NQA: Biologic Material, Dental

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: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [Straumann Emdogain]

• 07630031730046: Straumann Emdogain, 5 x 0.7 ml (30mg/ml)
• 07630031730039: Straumann Emdogain, 5 x 0.3 ml (30 mg/ml)
• 07630031730022: Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.7 ml (30 mg/ml), Straumann PrefGel 3 x 0.
• 07630031730015: Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel 3 x 0.
• 07630031729989: Straumann Emdogain, 5 x 0.15 ml (30 mg/ml)
• 07630031747389: Straumann Emdogain MI 0.3ml
• 07630031747372: Straumann Emdogain MI 0.15ml