Ora-Aid

GUDID 08800026800408

TBM Corporation

General oral wound dressing, non-animal-derived, non-sterile

• Primary Device ID: 08800026800408
• NIH Device Record Key: b0d58f40-8135-411e-8ab5-6c6d2842f2f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ora-Aid
• Version Model Number: OB53
• Company DUNS: 688452907
• Company Name: TBM Corporation
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com
• Phone: +82629712845
• Email: admin@tbmkorea.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026800156 [Primary]
GS1	08800026800408 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211851

FDA Product Code

• OLR: Oral Wound Dressing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-29
• Device Publish Date: 2022-06-21

On-Brand Devices [Ora-Aid]

• 08800026800408: OB53
• 08800026800149: OB23