AccessGUDID - DEVICE: Softspan Tissue Expander (00812790029211)

GUDID

Device Identifier (DI) Information

Brand Name: Softspan Tissue Expander
Version or Model: BTE500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BTE500
Company Name: Sientra, Inc.

Primary DI Number: 00812790029211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010209877 *Terms of Use

Device Description: Tissue Expander, Bauer Design, Smooth Surface, Remote Port, Reinforced Base, 500-600 cc

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
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	Expander, Skin, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070303	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Volume: 500-600 cc

Device Record Status

Public Device Record Key: bf2a2e9b-1f5a-45fe-bcb1-a4b1300f9f1b
Public Version Date: October 25, 2023
Public Version Number: 2
DI Record Publish Date: May 07, 2021