Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSM-400

GUDID 07445161010421

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 400 cc

Establishment Labs S.A.

Silicone gel-filled breast implant, smooth-surface

• Primary Device ID: 07445161010421
• NIH Device Record Key: 97ee3c1c-5276-4d02-8540-c0239d3f5af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motiva® SmoothSilk® Round Ergonomix Breast Implant
• Version Model Number: ERSM-400
• Catalog Number: ERSM-400
• Company DUNS: 853166098
• Company Name: Establishment Labs S.A.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07445161010421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230005

FDA Product Code

• FTR: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Sterilization

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

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

[07445161010421]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [Motiva® SmoothSilk® Round Ergonomix Breast Implant ]

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• 07445161012043: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
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• 07445161010834: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 625 c
• 07445161010827: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 550 c
• 07445161010810: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 500 c