IH FreeMilling Abutment AIHFMRH4510

GUDID 08800041348824

SEWON MEDIX IH FreeMilling Abutment Regular Hex Set Product, Ø4.5x1.0mm

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041348824
• NIH Device Record Key: e180c5cc-1cc5-40eb-a4bf-ddae459b14ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH FreeMilling Abutment
• Version Model Number: AIHFMRH4510
• Catalog Number: AIHFMRH4510
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• Device Count: 1
• 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: false
• Donation Id Number: false
• 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	08800041348824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-02-25

On-Brand Devices [IH FreeMilling Abutment]

• 08800041349159: SEWON MEDIX IH FreeMilling Abutment Regular Non-Hex Set Product, Ø4.5x1.0mm
• 08800041349128: SEWON MEDIX IH FreeMilling Abutment Mini Non-Hex Set Product, Ø4.5x1.0mm
• 08800041348886: SEWON MEDIX IH FreeMilling Abutment Regular Hex Set Product, Ø5.5x1.0mm
• 08800041348855: SEWON MEDIX IH FreeMilling Abutment Regular Hex Set Product, Ø5.0x1.0mm
• 08800041348794: SEWON MEDIX IH FreeMilling Abutment Mini Hex Set Product, Ø4.5x1.0mm
• 08800041348824: SEWON MEDIX IH FreeMilling Abutment Regular Hex Set Product, Ø4.5x1.0mm
• 08800041349081: SEWON MEDIX IH FreeMilling Abutment Regular Hex-Guide Set Product, Ø6.0x3.0mm
• 08800041349050: SEWON MEDIX IH FreeMilling Abutment Regular Hex-Guide Set Product, Ø5.5x3.0mm
• 08800041349043: SEWON MEDIX IH FreeMilling Abutment Regular Hex-Guide Set Product, Ø5.5x2.0mm
• 08800041349036: SEWON MEDIX IH FreeMilling Abutment Regular Hex-Guide Set Product, Ø5.5x1.0mm