Motiva® SmoothSilk® Round Breast Implant RSF-550+Q

GUDID 07445161002969

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 550 cc

Establishment Labs S.A.

Silicone gel-filled breast implant, smooth-surface

• Primary Device ID: 07445161002969
• NIH Device Record Key: 8158dacf-69a0-4801-929c-549cac17ab98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motiva® SmoothSilk® Round Breast Implant
• Version Model Number: RSF-550+Q
• Catalog Number: RSF-550+Q
• Company DUNS: 853166098
• Company Name: Establishment Labs S.A.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07445161002969 [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

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

Dry Heat Sterilization

[07445161002969]

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 Breast Implant ]

• 07445161002976: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 625 cc
• 07445161002969: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 550 cc
• 07445161002952: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 500 cc
• 07445161002945: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 450 cc
• 07445161002938: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 425 cc
• 07445161002921: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 400 cc
• 07445161002914: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 375 cc
• 07445161002907: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 355 cc
• 07445161002891: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 335 cc
• 07445161002884: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 315 cc
• 07445161002877: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 295 cc
• 07445161002860: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 275 cc
• 07445161002853: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full with Qid 255 cc
• 07445161002778: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 525 cc
• 07445161002761: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 475 cc
• 07445161002754: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 425 cc
• 07445161002747: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 380 cc
• 07445161002730: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 360 cc
• 07445161002723: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 340 cc
• 07445161002716: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 320 cc
• 07445161002709: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 300 cc
• 07445161002693: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 285 cc
• 07445161002686: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 265 cc
• 07445161002679: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 245 cc
• 07445161002662: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 230 cc
• 07445161002655: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 215 cc
• 07445161002648: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi with Qid 205 cc
• 07445161002563: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 400 cc
• 07445161002556: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 360 cc
• 07445161002549: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 310 cc
• 07445161002532: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 290 cc
• 07445161002525: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 275 cc
• 07445161002518: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 260 cc
• 07445161002501: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini with Qid 245 cc
• 07445161002174: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 625 cc
• 07445161002167: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 550 cc
• 07445161002150: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 500 cc
• 07445161002143: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 450 cc
• 07445161002136: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 425 cc
• 07445161002129: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 400 cc
• 07445161002112: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 375 cc
• 07445161002105: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 355 cc
• 07445161002099: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 335 cc
• 07445161002082: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 315 cc
• 07445161002075: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 295 cc
• 07445161002068: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 275 cc
• 07445161002051: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 255 cc
• 07445161001979: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 525 cc
• 07445161001962: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 475 cc
• 07445161001955: Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 425 cc