AccessGUDID - DEVICE: Flora™ Tissue Expander SMOOTHSILK® (07445161020895)

GUDID

Device Identifier (DI) Information

Brand Name: Flora™ Tissue Expander SMOOTHSILK®
Version or Model: M-12-375
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M-12-375
Company Name: Establishment Labs S.A.

Primary DI Number: 07445161020895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 853166098 *Terms of Use

Device Description: Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé Medium Height 375cc

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
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?
45187	Skin-port tissue expander	An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LCJ	Tissue Expander And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211676	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: 91eefa33-8135-4743-a12f-d6bf99b0f9e9
Public Version Date: December 08, 2023
Public Version Number: 1
DI Record Publish Date: November 30, 2023