AccessGUDID - DEVICE: Motiva® SmoothSilk® Round Ergonomix Breast Implant (07445161010759)

GUDID

Device Identifier (DI) Information

Brand Name: Motiva® SmoothSilk® Round Ergonomix Breast Implant
Version or Model: ERSF-335
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ERSF-335
Company Name: Establishment Labs S.A.

Primary DI Number: 07445161010759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 853166098 *Terms of Use

Device Description: Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Full 335 cc

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64081	Silicone gel-filled breast implant, smooth-surface	An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTR	Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230005	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b0c3c5e-893e-4764-acdb-3663ea44f84b
Public Version Date: October 14, 2024
Public Version Number: 1
DI Record Publish Date: October 04, 2024