Healing Cap

GUDID 08800090600034

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system

• Primary Device ID: 08800090600034
• NIH Device Record Key: ca5b9833-428c-4bc4-8a00-8148fea9d7d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Cap
• Version Model Number: MAHC Cap 4.5
• Company DUNS: 631169224
• Company Name: InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800090600034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192197

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800090600034]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [Healing Cap]

• 08800090600034: MAHC Cap 4.5
• 08800090600027: MAHC Cap 5.5
• 08800090600980: MP CAP5.5
• 08800090600973: MP CAP4.5
• 08800039304597: MP CAP 5.5
• 08800039304580: MP CAP 4.5
• 08800039393621: MP CAP5.5L
• 08800039393614: MP CAP5.5S
• 08800039393607: MP CAP4.5L
• 08800039393591: MP CAP4.5S