Straumann Emdogain 075.133

GUDID 07630031747389

Straumann Emdogain MI 0.3ml

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
Primary Device ID07630031747389
NIH Device Record Keyaf8fb999-2825-4be1-b461-54fd94e7a9b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann Emdogain
Version Model NumberEmdogain
Catalog Number075.133
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com
Phone+1(801)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter
Total Volume0.3 Milliliter
Total Volume0.6 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031747389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQABiologic material, dental

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

On-Brand Devices [Straumann Emdogain]

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

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