Motiva® SmoothSilk® Round Ergonomix Breast Implant ERSF-375

GUDID 07445161010773

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 375 cc

Establishment Labs S.A.

Silicone gel-filled breast implant, smooth-surface

• Primary Device ID: 07445161010773
• NIH Device Record Key: e492710e-bdbd-4e5b-b716-e5c0f8784b9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motiva® SmoothSilk® Round Ergonomix Breast Implant
• Version Model Number: ERSF-375
• Catalog Number: ERSF-375
• 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	07445161010773 [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

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

Dry Heat Sterilization

[07445161010773]

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]

• 07445161012432: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full with
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• 07445161012241: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with
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• 07445161012142: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with
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• 07445161012081: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with
• 07445161012074: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi with
• 07445161012043: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161012036: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161012029: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161012012: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161012005: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011992: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011985: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011978: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011961: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011954: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011947: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011930: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011923: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011916: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011909: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 07445161011893: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini with
• 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