IH Angled Abutment AIHAARA504015C

GUDID 08800041339105

SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø5.0x4.0mm 15°

sewon medix Inc.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800041339105
• NIH Device Record Key: 010ef38b-aa1a-4340-96c4-7845138817f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH Angled Abutment
• Version Model Number: AIHAARA504015C
• Catalog Number: AIHAARA504015C
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041339105 [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: 2019-05-31

On-Brand Devices [IH Angled Abutment]

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• 08800041342235: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type Non-Coating Set Product, Ø4.5x3.0mm 25°
• 08800041342167: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type Non-Coating Set Product, Ø4.5x3.0mm 15°
• 08800041342112: SEWON MEDIX IH Angled Abutment Mini Hex_A-Type Non-Coating Set Product, Ø4.5x4.0mm 25°
• 08800041342044: SEWON MEDIX IH Angled Abutment Mini Hex_A-Type Non-Coating Set Product, Ø4.5x4.0mm 15°
• 08800041342006: SEWON MEDIX IH Angled Abutment Mini Hex_A-Type Non-Coating Set Product, Ø4.5x2.0mm 15°
• 08800041339174: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø5.0x4.0mm 25°
• 08800041339136: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø5.0x2.0mm 25°
• 08800041339105: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø5.0x4.0mm 15°
• 08800041339068: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø5.0x2.0mm 15°
• 08800041338993: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø4.5x2.0mm 25°
• 08800041338924: SEWON MEDIX IH Angled Abutment Regular Hex_A-Type TiN-Coating Set Product, Ø4.5x2.0mm 15°
• 08800041338856: SEWON MEDIX IH Angled Abutment Mini Hex_A-Type TiN-Coating Set Product, Ø4.5x2.0mm 25°
• 08800041338788: SEWON MEDIX IH Angled Abutment Mini Hex_A-Type TiN-Coating Set Product, Ø4.5x2.0mm 15°