Ora-Aid

GUDID 08800026800149

TBM Corporation

General oral wound dressing, non-animal-derived, non-sterile
Primary Device ID08800026800149
NIH Device Record Key3f28930a-1e42-4b3b-988d-1273ffaff40e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOra-Aid
Version Model NumberOB23
Company DUNS688452907
Company NameTBM Corporation
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com
Phone+82629712845
Emailadmin@tbmkorea.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026800149 [Primary]
GS108800026800392 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLROral Wound Dressing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-29
Device Publish Date2022-06-21

On-Brand Devices [Ora-Aid]

08800026800408OB53
08800026800149OB23

Trademark Results [Ora-Aid]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORA-AID
ORA-AID
97646538 not registered Live/Pending
TBM Corporation
2022-10-25
ORA-AID
ORA-AID
87490499 not registered Live/Pending
TBM Corporation
2017-06-15

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