Straumann Emdogain 075.129W

GUDID 07630031730046

Straumann Emdogain, 5 x 0.7 ml (30mg/ml)

Institut Straumann AG

Periodontal root surface regeneration material
Primary Device ID07630031730046
NIH Device Record Keyfa99cc1f-39ef-410d-9668-b4b65086adb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraumann Emdogain
Version Model NumberEmdogain
Catalog Number075.129W
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com
Phone1 800 4488168
Emailinfo.usa@straumann.com

Device Dimensions

Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 Milliliter
Total Volume3.5 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
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
GS107630031730046 [Primary]
GS107630031747037 [Unit of Use]

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 Date2019-03-14
Device Publish Date2019-03-06

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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