Straumann Emdogain 075.128W

GUDID 07630031730039

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

Institut Straumann AG

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